EMERGO SUMMARY OF KEY POINTS:

• List of Class II medical devices exempt from 510(k) requirements now finalized by US FDA
• More than 1,000 devices are now exempt from 510(k) premarket notification requirements
• The FDA first proposed these 510(k) exemptions in March 2017.

The US Food and Drug Administration has finalized a list of more than 1,000 medium-risk medical devices that will no longer require 510(k) premarket notification in order to obtain market authorization.

The FDA’s finalized 510(k) exemptions follow the agency’s publication in March 2017 of a list identifying 1,003 Class II devices whose risks the agency argued were well enough understood that premarket notification reviews were not necessary. The agency identified the Class II devices for exemption in order to meet streamlining mandates of the 21^st Century Cures Act of 2016.

What affected US 510(k) medical device registrants should do

Along with finalization of its list of exempted devices, the FDA has provided registrants of affected Class II devices with recommendations for next steps, such as:

• Manufacturers with existing 510(k) registrations do not have to take any immediate actions
• US market applicants with pending 510(k) registrations should get in touch with their lead FDA reviewers to determine whether their devices fall under the new exemption rules.
• Manufacturers as well as importers and distributors should review their registration information to see whether they should continue using their existing product codes that require 510(k) premarket notification, or if their devices qualify for new product codes and exemption from 510(k) requirements.
• Manufacturers whose devices are exempt may need to amend their Unique Device Identification (UDI) data in the Global Unique Device Identification Database (GUDID).

Emergo will continue monitoring these developments and alert readers if the FDA announces additional steps affected 510(k) registrants should take.

Additional FDA 510(k) resources from Emergo:

• US FDA 510(k) registration support for medical device companies
• FDA QSR (21 CFR Part 820) quality system compliance consulting
• Whitepaper: Preparing an FDA 510(k) submission
• Video overview: The US FDA medical device regulatory process