October 7, 2013 @ 6:00 PM – 7:00 PM
LIVE Online Seminar (LIVE Webinar)
Global Compliance Seminar
731-Go to GCS (468-6427)

LIVE Online Seminar | Biocompatibility Testing for Medical Devices

Title: Understanding and Addressing the Regulatory Requirements for Medical Device Biocompatibility Testing

  • Date: Starting from October 7 (Monday), 2013
    • NOTE: This seminar recurrs monthly on first Monday.
    • Choose a date of your preference below when you register.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes

About the Seminar

This seminar is intended to help device industry better understand and address the regulatory requirements for the appropriate biocompatibility testings applicable for medical devices.

When preparing Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Investigational Device Exemption Applications (IDEs), Humanitarian Device Exemptions (HDEs), or de novo petitions, the potential toxicity of the device materials is determined for medical devices (either sterile or non-sterile) that come into direct or indirect contact with the human body. Thus, appropriate biocompatibility testing should be conducted for biological evaluation of a medical device.

Over the years, the regulatory requirements for biological evaluation of medical devices have been evolved as new device components are developed and introduced.  It is imperative that device industry better understand, update and implement the regulatory requirements for the biocompatibility tests appropriate for medical devices.

In this 60-min presentation, the speaker will update regulatory information including new considerations and the use of the international standards and further guide you through the details of the biocompatibility testing requirements applicable to various medical devices.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Applicable standards
  3. FDA guidance documents
    • Note: different device types are discussed in each seminar.
  4. How to use previous data available (previous submission or use of previous animal safety studies to justify)
  5. How to use data available from vendors or suppliers of device components or materials including public information (literature and databases)
  6. How to determine which tests to be conducted including device materials or a composite of the finished device or both
  7. Test selection
    • Acute systemic toxicity
    • Biodegradation
    • Carcinogenicity
    • Cytotoxicity
    • Genotoxicity
    • Hemocompatibility
    • Implantation tests
    • Irritation tests
    • Pyrogenicity
    • Reproductive and developmental toxicity
    • Sensitization assays
    • Subchronic toxicity
  8. Testing considerations (sample preparation: extracting media and extraction conditions)
  9. How to justify omission of a biocompatibility test
  10. How to assess known or potentially toxic chemicals
  11. How to address or document when changes occur (e.g., processing, sterilization and formulation).
  12. Documentation (device and device components)
  13. Contents of biocompatibility test reports
  14. How to present in your documents for regulatory submission

About the Intended Attendee(s)

  • R&D
  • Regulatory Affairs
  • Clinical Affairs
  • Quality
  • Anyone interested in the topic and/or handling regulatory 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 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.  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. Currently Dr. Lim is an adjunct professor in regulatory affairs at Northeastern University in Boston, MA.


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LIVE Online Seminar | Biocompatibility Testing for Medical Devices