In Bloomberg Law, Joshua Oyster Discusses FDA Guidance for AI-Enabled Medical Device Changes

In The News
January 6, 2025
Attorneys:

The U.S. Food and Drug Administration recently published final guidance that outlines how manufacturers can submit a predetermined change control plan (PCCP) to obtain preapproval for slight changes to medical devices after they are on the market. It also outlines how the agency will oversee AI platforms as they change and learn when used with patients.

In a Bloomberg Law article, life sciences regulatory & compliance partner Joshua Oyster explains that the PCCP is a concept that eases regulatory burdens by potentially reducing the number of regulatory submissions. It should be something the Trump administration is aligned with.

“Having a functioning PCCP process that is workable to industry and is providing flexibility is going to be really important over the next few years as companies try to innovate and develop new products,” said Joshua.