Decision Criteria: New FDA Guidance Impacting the Requirement for 510(K) Clearance of Modified Devices
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In October 2017, the FDA issued two final guidance documents which outline when a change to an existing device necessitates a 510(k) filing, formally titled “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”. These guidances were originally published as draft recommendations in August 2016, and largely remain consistent with further explanation and details on guiding principles. 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 the new guidance will provide manufacturers with a greater understanding of the FDA’s expectations in the current regulatory environment.
- Important changes in device and software modification guidances
- Common software changes that might require a 510(k) filing
- Case study analysis on instances requiring/not requiring a new 510(k)