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Dive Brief:

  • The Food and Drug Administration is considering a master file pilot program for approved medical devices that are sterilized using radiation, including gamma radiation.
  • The proposed pilot program is in response to “global supply chain constraints” and is intended to “support sterilization supply chain resiliency,” the agency said in a statement. The FDA envisages the program helping premarket approval holders advance alternative ways to sterilize their medical devices.
  • Interest in alternative methods of device sterilization has increased as the environmental impact of ethylene oxide (EtO) has come under scrutiny, leading the FDA to create a Sterility Change Master File Pilot Program and innovation challenges.

Dive Insight:

The agency new pilot program is still under consideration. The FDA set out why it is considering enacting the pilot program in an update to a webpage that sets out its current position on the sterilization of medical devices. 

“The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency,” the regulator wrote. “If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.”

The FDA already has determined that the pilot program will exclude medical devices cleared under the 510(k) pathway. Radiation is an established category A sterilization method for 510(k)-cleared devices, as set out by the agency in its guidance on the submission and review of sterility information for products labeled as sterile.

In its discussion of the proposed PMA pilot program, the FDA explained that “changes from one established category A method to another established category A method, including a change from gamma to another radiation source, would generally not need a new 510(k).” A new 510(k) is unnecessary if the change does not “significantly affect the performance or biocompatibility of the device, or constitute a major change or modification in the intended use of the device,” the agency added.

The FDA opened up a pilot program for 510(k) holders last month. The initiative, which is open to all current 510(k) holders, is designed to help companies switch from a fixed chamber EtO sterilization cycle to the sterilization method described in the master file. If certain conditions are met, companies can reference the master file to make the change rather than submit a new 510(k).

The agency is encouraging participants in its sterilization innovation challenges to consider taking part in the 510(k) pilot program.

The various programs form part of a push to rethink how devices are sterilized, including by using lower levels of existing sterilizing agents and by switching to new agents. The FDA said it’s working with sterilization experts, medical device manufacturers and other government agencies on the initiative.

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