On 26 November 2018, the US Food and Drug Administration (FDA) announced various plans and proposals to notably change and modernize its premarket notification (510(k)) clearance process which it uses to authorize US marketing of most medical devices. The vast majority of medical devices requiring US marketing authorization go through the 510(k) process. As part of the 510(k) process, manufacturers generally rely on comparative testing against a legally marketed predicate device to show that a new device is as safe and effective as and substantially equivalent to the predicate device. FDA believes that change is needed to limit reliance on older predicate devices as a basis of comparison in favor of newer ones and to also encourage more reliance on objective safety and performance criteria as part of the 510(k) process. The Agency also believes that this type of change will help it and industry to better keep pace with the increasing complexity of quickly evolving medical device technology.

FDA's anticipated plans and proposals include the following:

1. In the next few months, the FDA Center for Devices and Radiological Health (CDRH) is considering making public on its website those 510(k)-cleared devices that used "older" predicate devices to show substantial equivalence to a legally marketed predicate. For purposes of what constitutes "older", FDA is considering focusing on use of predicate devices that are more than 10 years old as the cut-off. FDA plans to seek public feedback on this measure before proceeding. It is interested in stakeholder feedback on:

  • Whether this measure is supported or not and why;
  • Whether other criteria should inform FDA's decision on what devices to post on its website; and
  • Whether there are other actions the Agency should take to promote the use of more modern predicate devices.

2. FDA also is developing proposals to potentially "sunset" use of certain older medical devices as predicate devices, especially in cases where FDA has seen safer or more effective technology emerge. FDA realizes that this action may require a change in the Federal Food, Drug, and Cosmetic (FDC) Act by Congress.

3. Early next year, FDA also intends to finalize a guidance document establishing an alternative 510(k) pathway that allows manufacturers of certain well-understood device types to rely on modern objective safety and performance criteria to demonstrate substantial equivalence. These criteria would reflect the safety and performance of modern predicate devices. Eventually, FDA would like to expand this alternative approach for broad use across the 510(k) program and make it the primary 510(k) review mechanism for medical devices requiring 510(k) clearance. In other words, FDA would like this pathway to eventually supplant the practice of manufacturers comparing their new devices to a specific predicate device. FDA is planning to name this new approach the "Safety and Performance Based Pathway."

4. FDA would like more streamlined processes which would improve its ability to quickly implement new special controls for a medical device to address safety concerns, as well as to up-classify a device type (eg, change it from Class II to Class III), where appropriate, in response to a safety concern. Again, more streamlined authority in these regards could require Congress to change the law.

5. As a result of its 510(k) policy proposals, FDA also believes that more medical device manufacturers will utilize the "de novo" classification process which permits an evaluation of novel devices without a predicate device and allows FDA to establish special controls for devices of the same type. An FDA proposed rule to clarify procedures and requirements for "de novo" classification requests is scheduled for publication in the Federal Register on 7 December 2018.

Please let us know if you have any questions regarding FDA's 510(k) or "de novo" classification programs or anticipated or possible changes to them.

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