Dive Brief:

• FDA on Thursday issued four finalized or updated guidance documents key to its effort to streamline the 510(k) marketing authorization pathway to promote faster access to new medical technologies.
• The group of documents covers the special 510(k) program, abbreviated 510(k) program, refuse to accept policy for 510(k)s, and format for traditional and abbreviated 510(k)s.
• FDA said the combined documents may conserve resources for both the agency and industry and without altering the statutory criteria for substantial equivalence.

Dive Insight:

FDA is focused on improving efficiency of its 510(k) review process, through which the majority of premarket device authorizations are made. The pathway is used for low- to moderate-risk devices that are substantially equivalent to a device already on the market known as a predicate device. 

Special 510(k) program

The special 510(k) program, established in 1998, is used by companies that want to make changes to their own devices. It is intended for well-defined device modifications where design control procedures produce results that can help form the basis for substantial equivalence.

FDA’s guidance clarifies the types of technological changes appropriate for review as special 510(k)s, including design and labeling changes. Under the approach, certain changes to the indications for use may be made. The focus is on whether methods to evaluate the changes are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.

Industry group AdvaMed, in comments on the initial draft of the guidance, said it agreed with the agency that broader use of the special 510(k) review pathway could result in more efficient use of FDA's resources while adequately protecting public health. It backed the removal of a requirement that indications for use be identical between the modified device and its predicate.

Abbreviated 510(k) program

The abbreviated 510(k) program is an alternative approach that uses guidance documents, special controls and voluntary consensus standards to aid FDA's premarket review of 510(k) submissions. Summary reports may be used to briefly describe the recommended testing performed to support the submission. The reports summarize the device description, manufacturer’s device design requirements, risk management information, and a description of test methods used to address performance characteristics.

Device manufacturers can pursue an abbreviated 510(k) when the submission relies on FDA guidance documents or a demonstration of compliance with special controls for the device type.

Refuse to accept policy for 510(k)s

The updated document explains the procedures and criteria FDA intends to use to determine whether a premarket notification 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

FDA said that because it has agreed to performance goals based on the timeliness of reviews, acceptance review takes on additional importance in encouraging quality submissions and allowing FDA to concentrate resources on complete submissions. The policy includes an early review against specific acceptance criteria, to inform the submitter within the first 15 calendar days after receipt of the submission if the request is administratively complete, or to identify the missing elements.

Format for traditional and abbreviated 510(k)s

The guidance, updated to align with changes to the special 510(k) program, describes how to format an original submission for a traditional or abbreviated premarket notification 510(k) submission. It offers a general framework for the format and content and does not describe recommendations for any specific device or premarket submission types.