EMERGO SUMMARY OF KEY POINTS:

• The US FDA has proposed exempting hundreds of Class II medical devices from 510(k) requirements.
• The exemptions are part of the 21^st Century Cures Act, passed in late 2016.
• Newly exempt devices will still need to meet other FDA regulations such as 21 CFR Part 820.

US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21^st Century Cures Act passed in late 2016.

Explaining the latest round of proposed Class II device exemptions, the agency stated that removing 510(k) requirements for these products will allow the agency to refocus resources on premarket reviews of devices that pose greater public health risks. Among other things, the 21^st Century Cures Act requires the agency to identify Class II device types for which reviewers no longer need reports of reasonable assurances of safety and effectiveness in order to grant clearance for the US market.

"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 agency states in its notice.

Which Class II devices now qualify for 510(k) exemption?

The FDA is using the same exemption criteria for its latest batch of Class II devices as laid out in a 1998 guidance.  

Currently, the FDA has set up roughly 2,800 product codes associated with devices that require 510(k) clearance. Based on an Emergo analysis of the agency’s proposed action, 337 Product Codes (or 12% of the total) will now be eliminated from premarket notification requirements.

Product codes affected by the FDA proposal include a broad array of medical devices and (many) IVD products:

• 30% of the exempted devices are clinical chemistry or clinical toxicology products
• 14% are hematology or immunology products
• The remaining devices include a mix of gastroenterology, urology, cardiovascular, dental, ENT, OB/GYN, surgical, ophthalmic and radiology products

However, the FDA emphasizes in its proposal that Class II devices exempt from 510(k) requirements must still meet other US regulatory obligations—including 21 CFR Part 820 Quality System Regulations.

Timeframe for new premarket notification exemptions

The FDA will accept comments from industry over the next 60 days, after which the agency will either finalize its list of exempt devices or make adjustments.

More FDA services and resources available from Emergo

• FDA 510(k) consulting for medical device companies
• FDA 21 CFR Part 820 medical device quality system consulting
• Whitepaper: Preparing a 510(k) premarket notification submission
• US FDA regulatory process chart

List of Class II devices the FDA is proposing to exempt from the FDA 510(k) process (sorted by Product Code):