About the Seminar
This seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register. Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.
In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.
The speaker will present how to implement the UDI system requirements in a CAC-SI manner.
*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.
In this 60-min presentation, the speaker will guide you through the details. You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.
About the Areas to Be Discussed
- Applicable Statute(S), Regulations and Enforcement Authority
- UDI Development History
- UDI Final Rules: Technical Requirements and Changes Made
- When to Use a UDI and When to Discontinue Its Use
- UDI System Requirements including Technical Standards
- Requirements for a Unique Device Identifier
- FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
- UDI Rules: Applicability
- UDI Rules: Exceptions and Alternatives
- Devices at a Retail Store
- Devices Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
- Devices Labeled Prior to Compliance Dates
- Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
- Class I Devices: cGMPs Exempted
- When to Request Exceptions and Modifications
- Which Devices Not Required to Have a Production Identifier
- Direct Marking Requirements and Revised Changes
- Requirements for Stand-Alone Software
- Use and Discontinuation of a UDI and When to Use a New UDI
- Compliance Dates for the Applicable Requirements Over Seven (7) Years
- Device Identifier Formats including Dates
- Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
- Impact of the Final Rules to Many Business Areas/Processes
- Changes in Device Design, Documentation and Manufacturing Processes
- Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
About the Intended Attendee(s)
- R&D Scientists, Managers, Directors, and VPs
- Regulatory Affairs and Compliance Professionals
- Clinical Affairs Professionals
- Quality Professionals
- Legal and Compliance Officers
- Marketing Professionals
- Senior Management
- 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 and guidance 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 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.
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