Sep 17, 2019

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Special and Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions.

Expanded access to Special 510(k) program

First, CDRH’s final Special 510(k) program guidance covers criteria for utilizing a less-burdensome 501(k) review for a modified medical device; Special 510(k) applicants may rely on their own design controls for proposed modifications.

According to Emergo by UL consultants, the final Special 510(k) guidance includes new criteria following the launch of a pilot program for this premarket notification program announced in 2018. Previously, FDA focused on whether changes were being proposed that would impact indications for use or alter fundamental scientific technology in order to determine eligibility of a device for Special 510(k) review.

Under the final guidance, FDA reviewers will examine whether methods chosen to assess proposed changes to a device are well-established, and whether results lend themselves to adequate review via summary or risk analysis formats.

Besides allowing certain modifications to indications for use, the Special 510(k) program also allows technological changes such as:

  • Proposed changes that are submitted by manufacturers legally authorized to commercialize devices in question;
  • Changes for which performance data are not necessary, or for which such data there are well-established evaluation methods are available;
  • Performance data needed to support substantial equivalence claims may be assessed and reviewed in summary or risk analysis formats.

These changes reflect FDA’s plans stated in 2018 to expand access for manufacturers whose devices undergo modifications to the Special 510(k) program and retain US market access.

Abbreviated 510(k) program for faster FDA clearance

Second, FDA and CDRH have finalized guidance on the Abbreviated 510(k) program, wherein manufacturers may utilize existing relevant FDA guidance documents, standards and special controls to qualify for expedited premarket notification review.

The final guidance identifies content to be included in an Abbreviated 510(k) application, including device indications for use and labeling data, summary reports of how any relevant guidance, special controls or standards support substantial equivalence claims, and any supplementary information to address issues not covered by guidance, controls or standards.

FDA Refuse to Accept policy updates to reflect 510(k) pathway changes

Last, FDA has finalized guidance updates from early 2019 to the agency’s Refuse to Accept policy that establishes minimum acceptability thresholds for medical device 510(k) submissions. FDA’s Refuse to Accept (RTA) guidance includes acceptance checklists for traditional as well as Abbreviated and Special 510(k) application routes.

US medical device market applicants should stay up to date on FDA’s RTA policy in order to avoid potentially costly registration delays.

Learn more about the US FDA 510(k) submission process at Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA Pre-Submission (Q-Sub) consulting for medical device manufacturers
  • In-depth video: The US FDA 510(k) clearance process
  • Whitepaper: Preparing a US FDA 510(k) submission







  • Stewart Eisenhart