The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country, according to a speaker at RAPS Convergence 2023.
PCCPs are a way for medical devices to change post-marketing authorization without the need for a supplemental application, provided the changes are prespecified in the plan, Hrishikesh Gadagkar, senior principal at RQM+, said at the meeting.
Currently, the agency’s draft guidance for AI/ML devices is the only guidance available on PCCPs. It is worth reviewing even if you don’t have software in your submission, Nancy Morrison, vice president, intelligence and innovation, at RQM+, told attendees (RELATED: FDA draft guidance allows AI/ML devices to evolve without requiring new submissions, Regulatory Focus 31 March 2023).
The agency is looking for engagement from sponsors on their plans surrounding PCCPs and about future submissions, and the Q-Submission process is a method for receiving FDA feedback before a marketing submission. However, PCCPs are not permitted in pre-submissions even though manufacturers can discuss their plans through the pre-submission process, Gadagkar noted (RELATED: FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance, Regulatory Focus 06 June 2023)…
