Kelliann H. Payne

Jan 15, 2025 | jdsupra.com | Suzanne Friedman |Kelliann H. Payne |Jodi Scott

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which consolidates the recommendations that FDA has been providing over the years on the content needed in a marketing application pertaining to a device with AI-enabled software functions in order to facilitate FDA’s determination as to the safety and effectiveness of the device...

Aug 30, 2024 | jdsupra.com | Suzanne Friedman |Kelliann H. Payne

A predetermined change control plan (PCCP) is documentation describing what modifications will be made to a device after its initial premarket authorization without requiring a new marketing submission to FDA, and how these modifications will be assessed. Modifications to medical devices that could affect the safety or effectiveness of the device require premarket authorization from FDA.

Aug 30, 2024 | lexology.com | Kelliann H. Payne |Suzanne Friedman

The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for modifications in advance by submitting a PCCP document, which would describe the anticipated changes and how they will be tested and implemented.

Oct 24, 2023 | law360.com | Lina R. Kontos |Kristin Zielinski Duggan |Kelliann H. Payne

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Sep 13, 2023 | jdsupra.com | Kristin Zielinski Duggan |Lina R. Kontos |Kelliann H. Payne

Since 2009, the average page count of a 510(k) premarket notification submission to the 510(k) Program has more than doubled, to over 1,000 pages, partially as a result of updated FDA policies surrounding premarket submission content requirements, and because medical devices are growing more complex and innovative.