The FDA made good on promises to provide more clarity and transparency in the agency’s 510(k) medical device review process with a new draft guidance issued at the end of the year.
The draft guidance details the watchdog agency’s expectations for 510(k) submissions, including a crowd-pleasing flowchart meant to help device makers determine whether they’ve met standards for demonstrating that their new product equivalency with an existing device.
This latest agency release doesn’t alter the existing 510(k) process or the FDA’s expectations from submissions, Centers for Devices & Radiological Health chief Jeffrey Shuren wrote in his inaugural post, on the agency’s newly minted FDAVoice blog.
"Instead, it makes the existing regulatory framework more transparent and predictable by clearly articulating many of the longstanding practices and policies underlying the 510(k) program," he wrote.
The new draft guidance outlines a number of aspects of agency review, including:
- When clinical data should be used to support a 510(k) application
- Submitting photographs and schematics
- Appropriate use of multiple predicates for demonstrating equivalency
- Criteria for identifying "different questions of safety and effectiveness"
- How to resolve discrepancies between the newly designed 510(k) flowchart and the Food, Drug & Cosmetic Act
- Characteristics to involve when defining "intended use"
- Ensuring 510(k) summaries are accurate and complete
In one particular point, the guidance does away with the "split predicate" option, through which device makers could use one cleared device as a predicate for "intended use" and another a predicate for "technological characteristics," A 510(k) & Science report (pdf) cited in the guidance calls the practice "inconsistent with the 510(k) regulatory standard."
The 510(k) process has been a touchy subject for med-tech over the last year, with industry arguing that the FDA’s process has become excessively complicated, unpredictable and time-consuming.
"Every year some 4,000 lower-risk devices are cleared for marketing using this streamlined process, the most common pathway to market for medical devices," Shuren wrote.
The new document aims to relieve some of the tension by providing a clear regulatory pathway to the U.S. market, Shuren wrote, pointing out two additional guidances released at the end of the year.
One details how a device maker can appeal a CDRH decision and the second outlines how the agency will manage product codes. All together, that brings the FDA’s count to 9 medical device draft guidances released this year.
When finalized, this latest 510(k) evaluation draft guidance will supercede the existing guidelines, which were written in 1986 and amended in 1998.
The FDA plans to provide a free online training program to walk industry through the 116-page guidance, Shuren wrote on the FDAVoice blog, a new communications effort the industry launched at the beginning of the year.
The FDA is seeking comment on the draft for the next 3 months.