FDA considers pilot for lower radiation levels for device sterilization

Regulatory NewsRegulatory News | 08 June 2022 |  By 

The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency is considering a pilot program to allow lower radiation levels for sterilization for premarket approved (PMA) products, though it would not apply to 510(k) devices. The pilot would include gamma radiation sterilization.
On 7 June, FDA said it was considering a master file pilot program for PMA device manufacturers who sterilize their products using radiation.
“The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency,” the agency said. “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.”
FDA notes that the program would not apply to the overwhelming majority of products on the market that are 510(k) cleared. The agency says those devices already have an established category A sterilization method as stated in the 2016 guidance titled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Regulators also note that the 2017 guidance titled, Deciding When to Submit a 510(k) for a Change to an Existing Device, states that changing the sterilization method from one established category A method to another established category A method generally does not require sponsors to submit new 510(k) applications as long as the change doesn’t significantly affect the performance or biocompatibility of the device, or constitute a major change or modification in the intended use of the device.

The news comes after FDA announced last month it was launching a Sterility Change Master File Pilot Program that would allow 510(k) devices that are sterilized using ethylene oxide (EtO) to potentially use other methods of sterilization or even reduce the amount of EtO used in their sterilization process. The use of EtO sterilization has been a controversial topic over the past few years with opponents of the method arguing that EtO sterilization plants near residential areas are responsible for a rise in cancer cases.
EtO sterilization is the most commonly used form of sterilization of medical devices because the gas is able to penetrate materials such as cardboard while also being able to get into hard-to-reach places on medical products.
While industry continues to maintain that the risk from EtO is overblown, FDA has held a public workshop on the topic where some of the recommendations included using alternative sterilization methods, such as radiation and using lower concentrations of EtO. (RELATED: CDRH Unveils Pilot Project for Sterilization Changes, Regulatory Focus 25 November 2022)
During the COVID-19 pandemic FDA has been extra cautious about potential supply chain shortages and has taken significant actions to ensure the availability of products such as facemasks and ventilator parts. Even though the agency is slowly easing back into some normalcy, supply chain shortages continue to be a major consideration.
FDA has issued draft guidances that require industry to report potential supply chain shortages such as one that would require companies to follow risk management plan (RMP) reporting. (RELATED: FDA asks manufacturers to develop risk management plans to avert shortages, Regulatory Focus 20 May 2022)
The agency has also issued a draft guidance specifically on reporting medical device and diagnostic shortages for public health emergencies that industry has complained is too broad and potentially could be too resource-intensive for manufacturers as well as regulators. (RELATED: Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome, Regulatory Focus 20 April 2022)

During recent hearings in Congress, FDA Commissioner Robert Califf lobbied lawmakers for additional authorities and dedicated resources to monitor and respond to supply chain disruptions. His comments stemmed from a recent infant formula shortage that FDA says it had limited powers to prevent. (RELATED: Califf uses budget hearing to advocate for resources, authority to monitor supply chains, Regulatory Focus 19 May 2022)


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