On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices. A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market.
Under the 510(k) process, device manufacturers rely on predicate devices to demonstrate the safety and efficacy of a new device. The guidance expands the concept of the Abbreviated 510(k), which demonstrates substantial equivalence by relying “on the use of guidance documents, special controls, and FDA-recognized consensus standards to facilitate 510(k) review.” The FDA believes the expanded Abbreviated 510(k) Program may improve the efficiency of 510(k) reviews. According to the FDA, the new approach will:
benchmark modern technology against modern standards, while at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products.
Under the new guidance, the FDA could find a new device to be as safe and effective as a legally marketed device where it meets the levels of performance for the same characteristics of the legally marketed device. A submitter may be able to meet the requirement to compare its device with a legally marketed device by, among other things, demonstrating that the device’s performance meets established performance criteria. The guidance states that performance expectations may be described in FDA guidance, FDA-recognized consensus standards, and/or special controls. The FDA will maintain a list of device types appropriate for the new pathway on the FDA website with the guidance documents that identify the performance criteria and testing methods recommended for each device type.
The guidance also requests comment on:
- Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
- Should the FDA consider using other criteria to inform its point of reference?
- Are there other and/or alternative actions FDA should take to promote the development and marketing of safer, more effective 510(k) devices?
- Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?
Comments are due by 11:59 p.m. on April 22, 2019 and may be submitted here.