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.
Stay Up To Date with Ropes & Gray
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
Stay in the loop with all things Ropes & Gray, and find out more about our people, culture, initiatives and everything that’s happening.
We regularly notify our clients and contacts of significant legal developments, news, webinars and teleconferences that affect their industries.