FDA Issues New Guidance Documents for Review for PCCP for Medical Devices

With a view to simplifying the process for submitting medical device updates or evolutions for Predetermined Change Control Plans (PCCPs), the FDA has issued new guidelines and is requesting input to contribute toward the final document.?

The PCCP documentation describes updates and modifications to devices that the FDA can review to ensure continued customer safety and effectiveness.? The guidelines include recommendations that make the process more detailed but more productive so the overall process becomes more efficient.?

The commentary period is open until November 20th, 2024 and you can review the guidelines and comment submission process here.??The FDA will be hosting a webinar on Tuesday, September 3rd on the draft guidance - view details and sign-up here.?

In related information, we also want to provide some additional notes:

Electronic Submission Template for Medical Device De Novo Requests

The FDA has issued a guidance document for the standards required for submitting De Novo Requests electronically - one of several steps the FDA is taking to meet its commitment to the development of more efficient submission processes.

The De Novo request regulatory pathway is for lower-risk medical devices without a predicate device.??View the guideline document and submit your comments here.? The final guidelines will go into effect from October 1st 2025.

FDA And Industry Procedures for Section 513(g) Requests

New guidance has been issued for your review on the topic of submitting, reviewing, and responding to requests for information on the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of the FD&C Act.

You can review the guidance document and submit your comments here.