To streamline the 510(k) approval process and promote faster access while guaranteeing the safety and efficacy of medical technologies, on September 13, 2019, FDA issued four updated guidance documents.

USA: FDA updates premarket authorization guidance documents for Medical Devices

Effective immediately, manufacturers intend to follow the premarket authorization pathway, designed for low- to moderate-risk Medical Devices that are substantially equivalent to a device already marketed in the U.S., will be required to make use of the following updated documents:

  • “The Abbreviated 510(k) Program”, an alternative approach that uses guidance documents, special controls and voluntary standards to facilitate 510(k) submission preparation by manufacturers and review by FDA, provides recommendations on an optional approach that may be used to demonstrate substantial equivalence in premarket notifications;
  • “The Special 510(k) Program”, employed by manufacturers who intend to make changes to their devices, outlines the factors to consider when determining if a change to an existing device is appropriate for submission through the Special 510(k) pathway;
  • “Refuse to Accept Policy for 510(k)s”, laying out the procedures and criteria used by FDA in assessing whether a 510(k) submission meets minimum threshold of acceptability and should be accepted for substantive review;
  • “Format for Traditional and Abbreviated 510(k)s”, updated to reflect the changes brought to the Special 510(k) program and current FDA policies, offers instructions on how to format an original Traditional or Abbreviated 510(k).

Although it provides the general framework for the format and the content for the premarket notification submissions, the latter does not offer recommendations regarding any specific device or submission type. For such information, the manufacturers are required to refer to the other aforementioned specific guidelines.