How to Decide When a Modified Device Requires a 510(K) Clearance

1 Hour and 5 Minute Video | King & Spalding

Determining when a modification to a legally marketed device triggers the need for a 510(k) is challenging.  Industry practice and FDA’s expectations are frequently not aligned.  This is evidenced by an uptick in FDA Warning Letters regarding design and claims-related changes to medical devices.  The following presentation will:

  • Describe the FDA legal and regulatory framework governing the 510(k) implications of device modifications.
  • Analyze the recent Warning Letters on this issue and provide insights into FDA’s current thinking.
  • Outline the common pitfalls that industry encounters when evaluating device modifications, and provide a step-wise process for analyzing changes to 510(k)-cleared devices and 510(k)-exempt devices consistent with FDA’s expectations.


Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Legal Counsel
  • Compliance Officers


This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.


Pamela Forrest
King and Spalding

Pamela Furman Forrest is a partner in King and Spalding’s FDA and Life Sciences Practice Group. Ms. Forrest joined the firm in 2007, and has nearly 20 years of experience in advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, reclassification, import/export issues, Investigational Device Exemption (IDE) requirements, and combination product issues. In addition, Ms. Forrest frequently assists medical device manufacturers, investment banks, and private equity funds with due diligence evaluations of FDA-regulated companies.


Lynette Zentgraft
King and Spalding


Lynette Zentgraft joined King and Spalding’s FDA and Life Sciences Practice Group as a Regulatory Submissions and Strategy Expert. Prior to joining King and Spalding, Ms. Zentgraft was a Senior Scientific Reviewer for medical devices at the Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation. There, her responsibilities included the review of premarket notification (510(k)), investigational device exemption (IDE), premarket approval (PMA) and other regulatory submissions. Ms. Zentgraft is a graduate of Rensselaer Polytechnic Institute where she received her Bachelor of Science degree in Biomedical Engineering in 1992. She also received her Masters degree in Applied Physics and Engineering in Biomedicine from Johns Hopkins University in 1998.

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