About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

• Statute(s) And Regulations
• Definitions
• Device Classification And Predicates
• 510(k) Program
• When 510(k)s Are Required
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards and Guidance
• 510(k) Contents And Format
• Common Pitfalls and How to Prevent Them
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for a Q-submission
• Best Practices for a 510(k) Preparation, Submission and Clearance
• Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get updated with the latest information and tips
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Intended Attendee(s)

• Regulatory Affairs
• R&D
• Clinical Affairs
• Quality
• Marketing
• Consultants
• Legal Counsel
• Compliance Officers
• Senior Management
• Anyone interested in the topic.

About the Seminar Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

• Statute(s) And Regulations
• Definitions
• Device Classification And Predicates
• 510(k) Program
• When 510(k)s Are Required
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards and Guidance
• 510(k) Contents And Format
• Common Pitfalls and How to Prevent Them
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for a Q-submission
• Best Practices for a 510(k) Preparation, Submission and Clearance
• Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get updated with the latest information and tips
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Intended Attendee(s)

• Regulatory Affairs
• R&D
• Clinical Affairs
• Quality
• Marketing
• Consultants
• Legal Counsel
• Compliance Officers
• Senior Management
• Anyone interested in the topic.

About the Seminar Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

• Statute(s) And Regulations
• Definitions
• Device Classification And Predicates
• 510(k) Program
• When 510(k)s Are Required
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards and Guidance
• 510(k) Contents And Format
• Common Pitfalls and How to Prevent Them
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for a Q-submission
• Best Practices for a 510(k) Preparation, Submission and Clearance
• Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get updated with the latest information and tips
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Intended Attendee(s)

• Regulatory Affairs
• R&D
• Clinical Affairs
• Quality
• Marketing
• Consultants
• Legal Counsel
• Compliance Officers
• Senior Management
• Anyone interested in the topic.

About the Seminar Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

• Date: December 8, 2016
  • This seminar recurs tri-monthly on second Thursdays.
• Time: 08:00 AM PST | 11:00 AM EST
• Duration: 60 Minutes

About the Seminar

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.

About the Areas to Be Discussed

• FD&C Act and its implementing regulations
• FDA reviewer’s duties and responsibilities
• Types and characteristics of FDA reviewers
• Working with (in)experienced reviewers: issues, challenges and solutions
• Applying emotional intelligence and negotiation skills
• Dealing with changing scope of information request
• Dealing with when the reviewer is not making his/her position clear
• Understanding and analyzing an FDA reviewer’s position: views and comments
• Responding to the FDA reviewer’s questions and additional information
• Handling when interaction and communication are not going anywhere
• Dealing with when retaliatory actions by the reviewer are perceived
• Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
• Practical, actionable, and sustainable strategies/solutions

About the Intended Attendee(s)

• Regulatory affairs in pharmaceutical and medical device industry
• Quality
• Legal counsel
• Compliance officers
• Consultants
• Regulatory agency personnel
• Anyone interested in the subject

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

LIVE (one attendee): $199 

Recorded: $249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded: $299 

• Date: June 15, 2017
• NOTE: This 510(k) LIVE seminar recurrs tri-monthly (every three month) on 3rd Thursdays.
• Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
• Time: 12:00 PM PST | 03:00 PM EST
• Duration: 60 Minutes

About the Seminar

This presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.  On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011.  To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get the latest information
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Areas to Be Discussed

1. Applicable statute(s), regulations, and definitions
2. Device classification
3. Who is subject to a 510(k)
4. FDA guidance for 510(k) program, issued on July 28, 2014
5. What actions require a 510(k) including three types of 510(k)s
6. How to identify a predicate(s), if any.
7. 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
8. e-Copy Program
9. Product type-specific 510(k) contents-recently cleared
   
10. What to include and address in 510(k) submissions.
11. 510(k) contents and format
12. How to present scientific, technical, and/or clinical data.
13. How to demonstrate substantial equivalence (SE).
14. How to increase 510(k) submission quality.
15. How to respond to FDA’s request of additional information.
16. How to resolve different opinions between the submitter and FDA reviewer(s), if any.
17. PASS-IT suggestions/recommendations

About the Intended Attendee(s)

• Professionals from Regulatory Affairs, R&D, Clinical Affairs, Quality
• Anyone interested in FDA 510(k) submissions.

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates (ensuring to address the applicable requirements) ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

• Statute(s) And Regulations
• Definitions
• Device Classification And Predicates
• 510(k) Program
• When 510(k)s Are Required
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards and Guidance
• 510(k) Contents And Format
• Common Pitfalls and How to Prevent Them
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for a Q-submission
• Best Practices for a 510(k) Preparation, Submission and Clearance
• Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get updated with the latest information and tips
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Intended Attendee(s)

• Regulatory Affairs
• R&D
• Clinical Affairs
• Quality
• Marketing
• Consultants
• Legal Counsel
• Compliance Officers
• Senior Management
• Anyone interested in the topic.

About the Seminar Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

• Statute(s) And Regulations
• Definitions
• Device Classification And Predicates
• 510(k) Program
• When 510(k)s Are Required
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards and Guidance
• 510(k) Contents And Format
• Common Pitfalls and How to Prevent Them
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for a Q-submission
• Best Practices for a 510(k) Preparation, Submission and Clearance
• Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get updated with the latest information and tips
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Intended Attendee(s)

• Regulatory Affairs
• R&D
• Clinical Affairs
• Quality
• Marketing
• Consultants
• Legal Counsel
• Compliance Officers
• Senior Management
• Anyone interested in the topic.

About the Seminar Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

• Statute(s) And Regulations
• Definitions
• Device Classification And Predicates
• 510(k) Program
• When 510(k)s Are Required
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards and Guidance
• 510(k) Contents And Format
• Common Pitfalls and How to Prevent Them
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for a Q-submission
• Best Practices for a 510(k) Preparation, Submission and Clearance
• Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get updated with the latest information and tips
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Intended Attendee(s)

• Regulatory Affairs
• R&D
• Clinical Affairs
• Quality
• Marketing
• Consultants
• Legal Counsel
• Compliance Officers
• Senior Management
• Anyone interested in the topic.

About the Seminar Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

• Date: December 8, 2016
  • This seminar recurs tri-monthly on second Thursdays.
• Time: 08:00 AM PST | 11:00 AM EST
• Duration: 60 Minutes

About the Seminar

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.

About the Areas to Be Discussed

• FD&C Act and its implementing regulations
• FDA reviewer’s duties and responsibilities
• Types and characteristics of FDA reviewers
• Working with (in)experienced reviewers: issues, challenges and solutions
• Applying emotional intelligence and negotiation skills
• Dealing with changing scope of information request
• Dealing with when the reviewer is not making his/her position clear
• Understanding and analyzing an FDA reviewer’s position: views and comments
• Responding to the FDA reviewer’s questions and additional information
• Handling when interaction and communication are not going anywhere
• Dealing with when retaliatory actions by the reviewer are perceived
• Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
• Practical, actionable, and sustainable strategies/solutions

About the Intended Attendee(s)

• Regulatory affairs in pharmaceutical and medical device industry
• Quality
• Legal counsel
• Compliance officers
• Consultants
• Regulatory agency personnel
• Anyone interested in the subject

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

• Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
• Option 2: you may request an invoice by email to  Global Compliance Seminar
• Option 3: you may purchase online below using a credit card or PayPal. 

LIVE (one attendee): $199 

Recorded: $249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded: $299 

• Date: June 15, 2017
• NOTE: This 510(k) LIVE seminar recurrs tri-monthly (every three month) on 3rd Thursdays.
• Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
• Time: 12:00 PM PST | 03:00 PM EST
• Duration: 60 Minutes

About the Seminar

This presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.  On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011.  To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.

About the Benefits to Attend

• Gain and receive great guidance on 510(k) preparation, submission and clearance
• Get the latest information
• Learn the critical areas and common mistakes
• Improve your current practice
• Recognize what is important
• Become better aware of and get familiar with the 510(k) process
• Much more

About the Areas to Be Discussed

1. Applicable statute(s), regulations, and definitions
2. Device classification
3. Who is subject to a 510(k)
4. FDA guidance for 510(k) program, issued on July 28, 2014
5. What actions require a 510(k) including three types of 510(k)s
6. How to identify a predicate(s), if any.
7. 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
8. e-Copy Program
9. Product type-specific 510(k) contents-recently cleared
   
10. What to include and address in 510(k) submissions.
11. 510(k) contents and format
12. How to present scientific, technical, and/or clinical data.
13. How to demonstrate substantial equivalence (SE).
14. How to increase 510(k) submission quality.
15. How to respond to FDA’s request of additional information.
16. How to resolve different opinions between the submitter and FDA reviewer(s), if any.
17. PASS-IT suggestions/recommendations

About the Intended Attendee(s)

• Professionals from Regulatory Affairs, R&D, Clinical Affairs, Quality
• Anyone interested in FDA 510(k) submissions.

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates (ensuring to address the applicable requirements) ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.