How to Decide When a Modified Device Requires a 510(K) Clearance under New FDA Draft Guidances

1 Hour Video | Lynette Zentgraft and Elaine Tseng, King & Spalding

Determining when a modification to a legally marketed medical device triggers the need for a 510(k) application is a significant and ongoing challenge for regulatory professionals, and an area where industry practice and FDA expectations often differ. The FDA recently issued two draft guidance documents which aim to clarify when a modified device requires clearance of a new 510(k).  The following presentation will discuss the key take-aways from FDA’s new draft guidance documents, including implications for common industry practices, and recommendations industry should consider to help ensure that decision-making regarding device modifications is  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








Elaine H Tseng
King & Spalding LLP

Elaine Tseng is a partner with King & Spalding’s FDA & Life Sciences Practice Group in San Francisco. She previously served as Regulatory Counsel at the U.S. Food and Drug Administration, where she received the U.S. Secretary of Health and Human Services’ Distinguished Service Award and other FDA honors. In addition to her government experience, Elaine’s advising is enriched by her in-house experience in the life sciences industry, where she served as corporate regulatory counsel under secondment at a multinational life sciences company. Elaine has more than 15 years of experience specializing in FDA matters with a particular focus on pre- and postmarket regulatory requirements and policies applicable to medical devices and diagnostic products, including ophthalmic, orthopedic, cardiovascular, and neurovascular devices, in vitro diagnostic devices (IVDs) and laboratory developed tests (LDTs), software products, and drug/biologic/device combination products. She also has substantial experience with FDA regulation of pharmaceuticals, including biopharmaceuticals, and tissue products (hCT/Ps).







Lynette A Zentgraft
King & Spalding LLP

Lynette Zentgraft joined King & Spalding’s FDA & Life Sciences Practice Group as a Regulatory Submissions and Strategy Expert. Prior to joining King & 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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