FDA Seeks To Ease Approval Requirements for Moderate Risk Medical Devices

Federal regulators are considering changes that would make it easier for medical device manufacturers to gain approval to sell surgical clamps, dentures, catheters and hundreds of other types of products widely used throughout the U.S. However, some critics worry that rolling back regulations may expose consumers to an unnecessary risk of dangerous and defective medical devices. 

The FDA published a notice (PDF) in the Federal Register earlier this month, indicating that the agency intends to allow certain new Class II medical devices to be approved without having to undergo premarket notification requirements, in accordance with the recently passed “21st Century Cures Act”.

The agency is accepting public comment on the move for 60 days from March 14, before it makes a final determination, according to the notice.

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The proposal has raised concerns that medical devices may hit the market without even a modicum of review, allowing many more products than before to be approved through an even less restrictive version of the FDA’s controversial 510(k) program, meaning there would undergo no clinical trials or review, and approval would be based on whether they are substantially equivalent to a device already on the market.

“FDA’s final action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation,” the Federal Register notice states. “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.”

The FDA was required to post the proposed list of devices within 90 days of passage of the “21st Century Cures Act”, which was signed into law on December 13, 2016.

Consumer and patient safety advocates have already been raising concerns about steps the FDA has taken that make it too easy for untested medical devices to reach the market in the U.S. Many devices that are approved based on claims that they are “substantially equivalent” to existing devices, are marketed as featuring superior features, new manufacturing processes, materials, and surgical techniques that have never been seen or used before. Critics warn that the “21st Century Cures Act” will make it even easier for dangerous and defective medical devices to reach the market.

Rolling back regulatory oversight may further erode the ability of the FDA to protect patients from dangerous products, according to consumer advocates. A number of examples in recent years have highlighted the risks consumers face when untested devices are widely adopted in the medical field before dangerous defects are discovered based on post-marketing adverse event reports, essentially making U.S. patients unwilling test subjects.

Despite questions about the latitude already provided to manufacturers, the 21st Century Cures Act loosens the approval process further, allowing the agency to approve drugs and medical devices that have not had adequate clinical trials to ensure they are safe and effective, critics warn.

Comments are being accepted until May 15, 2017. They can be submitted electronically at https://www.regulations.gov or by writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions must indicate that they are for Docket No. FDA– 2017–N–1129 for ‘‘Medical Devices; Exemptions from Premarket Notification: Class II Devices.’’


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