HOW TO DECIDE WHEN A MODIFIED DEVICE REQUIRES A 510(K) CLEARANCE UNDER NEW FDA DRAFT GUIDANCES

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 The FDA recently issued two draft guidance documents which aim to clarify when a modified device requires clearance of a new 510(k). The following presentation will discuss the key take-aways from FDA’s new draft guidance documents, including implications for common industry practices, and recommendations industry should consider to help ensure that decision-making regarding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.

Speakers:
Lynette Zentgraft
Consultant
King & Spalding

Elaine Tseng
Partner
King & Spalding