FDA Looks to Exempt More than 300 Devices from 510(k) Requirements

Posted March 15, 2017

In a bid to ease what it described as “regulatory burdens,” the Food and Drug Administration (FDA) has published a list of nearly 340 Class II, moderate risk, medical devices that will be exempt from premarket notification requirements, known as 510(k)s.

In a statement, the FDA said it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. The agency periodically exempts from premarket notification review such medical devices when appropriate, the last time being in 2015.”

The publication of this notice on Tuesday marks the first provision of the recently passed 21st Century Cures Act that the FDA has implemented. Under section 3054 of the act, the FDA was required to publish a Federal Register notice that listed each type of Class II device that the agency had determined no longer required a report under section 510(k) of the Federal Food, Drug, & Cosmetic Act.

The agency noted that this “does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation.”

The list of exempted devices includes a number of tests and reagents, such as the over-the-counter benzodiazepine tests and cocaine enzyme immunoassays used for employment and insurance testing, as well as medical equipment ranging from umbilical clamps and obstetrical forceps to specific ophthalmoscopes and single-use endoscopic magnetic retrievers.

In the notice, the FDA explained that exempting these devices “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with federal regulation. Specifically, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”

According to a study published in 2010, it can cost a manufacturer upwards of $24 million to successfully go through the 510(k) process, with that money spent on tasks related to meeting FDA regulatory requirements. The fee itself is much lower; the standard 510(k) fee during fiscal year 2017 is $4,690.

The implications of the 21st Century Cures Act and the 2017 Medical Device User Fee Amendments, in addition to changes in international regulations, will be the focus of a two-day forum co-hosted by AAMI, the FDA, and BSI. The Symposium on the Evolving Standards and Regulatory Structure for Medical Devices will take place April 4–5 at the Hyatt Regency Dulles in Herndon, VA.

“We are experiencing a regulatory shift in many parts of the world, and there are a number of areas where we anticipate standards will change, such as risk management, cybersecurity, and health software,” said Joe Lewelling, vice president of emerging technology and health IT standards at AAMI. “The symposium is intended to clarify these changes to facilitate medical device approvals, as well as enhance understanding of postmarket regulatory requirements and promote the use of real-world evidence.”

The FDA will accept comments on its list via www.regulations.gov until May 15.