The Food and Drug Administration has issued draft updated recommendations to help medical device manufacturers determine when they are required to notify the regulatory agency about modifications made to certain devices already on the market, including separate guidance applicable to software devices.

Federal law requires manufacturers to submit a new 510(k) when changes or modifications are made to an existing medical device that could significantly affect its safety or effectiveness, or when the manufacturer makes a major change or modification in the intended use of the device.

The agency contends that the two guidances will provide “improved clarity” and “help ensure that the FDA receives appropriate submissions for modifications that do require premarket review.”

Updates in the draft guidance recommendations include:

  • Guiding principles, including recommendations for manufacturers to conduct a risk-based assessment to determine whether a modification could significantly affect the safety or effectiveness of the device.
  • Updated sections and flow charts to provide more clarity to manufacturers on when they likely are required to submit a new 510(k) for labeling, materials, technology, engineering and performance changes.
  • Examples of specific device changes that likely require a new 510(k) and ones that likely do not to help guide manufacturers during their own decision-making on whether to submit a new premarket notification.

According to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), the draft recommendations are “intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness.”

In addition, the FDA drafted separate guidance to address changes that are specific to software, complementing the general 510(k) modifications draft guidance.

When finalized, the guidances will replace a 1997 document entitled Deciding When to Submit a 510(k) for a Change to an Existing Device.

Bradley Merrill Thompson, an attorney at the Washington, DC-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, praised the agency for updating its recommendations for the industry.

“This guidance represents a very important—and previously missing—piece to the regulatory puzzle,” Thompson says. “The FDA has started to clarify when software such as mobile apps is regulated, but they left open the question of when changes to those apps that are regulated prompt the requirement of a new 510(k). This guidance finally tackles that issue, and it does so for all software, including that which is embedded in medical devices, that which is an accessory to a medical device, and that which functions as a stand-alone medical device. We have been sorely in need of this guidance for years, and are delighted to see it.”

The FDA is accepting comments regarding the draft document for the next 90 days. Comments can be submitted electronically here.

“I do hope that FDA is open-minded in reviewing comments, because I do believe in this particular instance the devil is in the details, and I expect the agency will get quite a few very useful and insightful comments,” concludes Thompson. “I hope that, unlike many other guidance documents, the agency moves promptly to make revisions and put this in final form after receiving comments.”

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