FDA issues new draft guidance on Class III de novos, UDI for small entities

The FDA issued a pair of new documents this week outlining the agency’s thinking on review of breakthrough medical devices and providing guidance for small companies trying to keep up with the new Unique Device Identifier program.

In a draft guidance proposed today the FDA offered some advice for companies developing novel devices that they believe are low-risk and thus eligible for more lenient review.

Under current FDA law, medical devices that truly have no equivalent or predicate on the market are automatically lumped in the Class III category, where they’re treated as high-risk and subject to the most stringent requirements. The de novo pathway allows manufacturers of unique devices to apply for a more relaxed review, but that used to require that companies 1st attempt and fail to win market clearance through the 510(k) medtech fast-track.

Under new guidelines companies no longer need to pass through the 510(k) pathway before applying for de novo review, a measure that the agency hopes will save time and both on all sides.

In the latest draft guidance the FDA provided some detailed criteria to help manufacturers determine when they may apply for de novo review and what types of materials to provide with their application, including for companies that have already made an attempt through the 510(k) process.

The agency recommended that companies apply for de novo review early through a pre-submission, or pre-sub.

"A pre-sub is not required in order to obtain FDA review of a de novo, but is a useful way for submitters to facilitate early feedback from FDA," according to the draft guidance. "A Pre-Sub would allow FDA to provide feedback on whether a device may be suitable for the de novo process and/or to advise you on the documentation needed in a subsequent de novo."

"The success of a de novo that is filed without a Pre-Sub will depend more heavily on  how well you search for a potential predicate device, identify the risks and special  controls (if applicable), and define and collect adequate data to provide reasonable assurance of safety and effectiveness," the FDA added.

In separate guidance finalized this week the FDA offered advice specific to small entities for compliance with the new Unique Device Identifier (UDI) rules. The new UDI program requires that manufacturers of all applicable medical devices prepare trackable labels and submit data for the FDA’s Global Unique Device Identification Database.

The new report outlines exceptions, details how the UDIs must appear, specifies data-keeping requirements and provides other program information articulated for small companies, defined as manufacturers with 500 or fewer employees or relabelers and repackagers with 100 or fewer employees. The UDI rule doesn’t provide exceptions or delays based on company size.

Read the FDA’s de novo draft guidance here.

Read the FDA’s small entity UDI guidance here.