Trial News

As part of an overhaul of the 510(k) medical device clearance process announced in November 2018, the FDA has released guidance for expanding its Abbreviated 510(k) Program, which clears medical devices for premarket approval that are “substantially equivalent” to existing devices, to include a new Safety and Performance Based Pathway for approval. The agency intends to change how device manufacturers can demonstrate that a new device is as safe and effective as the substantially equivalent device (known as the predicate device) through methods other than direct comparison testing.

Section 513 of the Federal Food, Drug, and Cosmetic Act provides an accelerated premarket approval process for medical devices that are substantially equivalent to one that is already approved, if the device “does not raise different questions of safety and effectiveness than the predicate device.” To modernize 510(k) clearance, the FDA issued a Medical Device Safety Action Plan last April that first identified the need to update the 510(k) program, which clears low and moderate risk devices that demonstrate a substantial equivalence to a predicate device. Eighty-two percent of devices cleared by the FDA in 2017 went through the 510(k) process.

The agency explained that it wants to ensure “that new devices are evaluated against advances in technology that can improve patient safety and performance” by removing older predicate devices and require that certain new devices “account for advances in technology or demonstrate that they meet more modern safety and performance criteria.”

Manufacturers use comparison testing of the newer device against the predicate to show that it is as safe and effective as the predicate. However, older predicate devices may not reflect advances in technology used in new devices, especially when internet-connected features are included in a new device. The agency is looking for ways to compare devices entering the market through 510(k) to newer devices and criteria.

Final agency guidance released on Feb. 1, 2019, addresses a new clearance pathway called the Safety and Performance Based Pathway. The pathway will be available under the Abbreviated 510(k) process, which can be used for a device when a guidance document exists, a special control has been established, or the FDA has recognized a relevant consensus standard. Traditional (any device) and Special (modifications to approved devices) processes also exist but will not include the new pathway.

Under the current process, manufacturers demonstrate safety and effectiveness through direct comparison testing with the predicate device. The guidance seeks to expand this to allow testing that shows that the new device meets the performance level of the existing device or established performance criteria. These criteria could be defined in FDA guidance or other consensus-based standards, or the agency will develop specific performance criteria based on one or more existing devices of the same type.

The guidance explains that the use of performance criteria would be appropriate only if the new device does not raise different safety and effectiveness issues from the predicate device, the criteria are in line with one or more legally marketed devices of the same type, and the new device meets all performance criteria.

The agency will provide more information on which types of devices would be appropriate to submit through this pathway, along with the performance criteria for each device type through guidance documents. It will still require manufacturers to identify an existing predicate device for the substantial equivalence analysis, and the current method of direct comparison will remain available.

When following an FDA-recognized standard, manufacturers will need to submit a declaration of conformity. When following performance criteria established by the agency, manufacturers must submit a summary of the testing data as well. If performance criteria do not rely on existing FDA standards, that data also must include the testing methodology and protocol that was used.