MDMA Files Comments to FDA on Predetermined Change Control Plans for Medical Devices

MDMA Files Comments to FDA on Predetermined Change Control Plans for Medical Devices

MDMA filed comments today on FDA's draft guidance, "Predetermined Change Control Plans for Medical Devices."  The draft guidance is the agency’s first step towards implementing the predetermined change control plan (PCCP) framework for all device types. MDMA believes that the PCCP framework has the potential, if fully implemented, to improve efficiency in the regulatory process for devices of all types, reduce regulatory burdens on both industry and FDA, and facilitate innovation and iterative improvements to medical devices. Most importantly, MDMA is confident that PCCPs can allow FDA and industry to deliver improved devices more efficiently to patients while ensuring that rigorous safety and effectiveness standards are upheld. 

In our comments, MDMA called attention to several concerns and recommendations which include: 

• FDA should clarify that manufacturers can establish a PCCP via the Special 510(k) pathway;

• FDA should consider congressional intent to streamline the regulatory process by allowing manufacturers to forego making subsequent premarket submissions for changes that are adequately described and planned for in a PCCP; and,

• FDA should assess whether the manufacturer’s existing risk management framework and Quality System would mitigate the risks of implementing a planned change that would otherwise require a subsequent marketing submission.

Thank you to all of our members who provided valuable input as we drafted our comments. To read our comment letter in full, please click here.