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FDA Draft Guidance Proposes Expansion of New Streamlined 510(k) Pathway

NEW YORK (GenomeWeb) – The US Food and Drug Administration today released a draft guidance describing an optional pathway that would ease the burden on device manufacturers demonstrating substantial equivalence for products within 510(k) applications.

The voluntary Expanded Abbreviated 510(k) program would allow sponsors to rely on performance characteristics laid out by the FDA to demonstrate substantial equivalence to a predicate device, instead of directly comparing their device to the predicate product.

In order to garner 510(k) clearance through the FDA for a new, moderate-risk device, manufactures need to compare it to an already marketed, or predicate device, and demonstrate substantial equivalence. Specifically, the sponsor must submit data from a direct comparison of the new product and predicate device with the same intended use and technological characteristics. Alternatively, if the new device has different technological characteristics than the predicate, it must demonstrate it is as safe and effective as the marketed product and doesn't raise new safety and efficacy questions.

In the draft guidance, the agency recognized that showing substantial equivalence through direct comparison of a new device to a number of predicate devices may be burdensome. While in some cases these burdens are necessary, the FDA also has found instances where the burdens may be eased.

As such, the FDA is proposing to expand its existing Abbreviated 510(k) program, which already allows submitters to demonstrate that some of the product's performance characteristics are substantially equivalent to a predicate device by showing conformity to FDA-recognized consensus standards, FDA guidance, and special controls. The Expanded Abbreviated 510(k) program, however, would allow submitters to use these same mechanisms to demonstrate substantial equivalence for all performance characteristics of a new product.

The FDA noted in the draft document that the use of performance criteria is only appropriate when a "new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate, the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device, and the new device meets the performance criteria."

FDA Commissioner Scott Gottlieb has publicly noted that this draft guidance was forthcoming.

The agency said in the draft guidance that it plans to provide information on the types of devices that are appropriate for this voluntary pathway. The FDA will also maintain a list of devices and guidance documents that discuss specific performance criteria for each type of device. 

The FDA can make use of reference consensus standards or portions of consensus standards that it recognizes, and establish special controls for a particular device type. As part of the application process, submitters have to identify a predicate device to facilitate analysis of the new product's intended use and technological characteristics.

However, instead of having to file the underlying data demonstrating substantial equivalence between the new and marketed devices, the sponsor can file a declaration of conformity, a summary of the data, or both, depending on the performance standards used to demonstrate substantial equivalence. The agency indicated, however, there may situations where it will request submitters file underlying data demonstrating substantial equivalence.

The public has 90 days to comment on the draft document starting April 12.