The U.S. Food and Drug Administration issued four separate guidances regarding the agency's 510(k) pathway for medical devices, the most popular pathway that manufacturers use to have products reviewed by the agency.
Released Sept. 12, the four finalized guidance documents cover the Special 510(k) Program, the Abbreviated 510(k) Program, the format for Traditional and Abbreviated 510(k) applications and the Refuse to Accept Policy for 510(k)s. Each document outlines the pathway for manufacturers and highlights ways to adhere to the agency's standards and requirements for each individual program.
The Centers for Devices and Radiological Health within the FDA is responsible for reviewing and approving medical device applications. The center can review thousands of applications every year, and the 510(k) pathway is the most popular pathway manufacturers use.
In a 2017 report, the U.S. Government Accountability Office, Congress' investigative arm, stated that over 61,000 applications were submitted to the 510(k) pathway between 2001 and 2016, compared to only 651 applications for the premarket approval pathway.
The 510(k) pathway is distinct because it lets manufacturers use a faster — and significantly cheaper — process for devices that can establish "substantial equivalence" with another device already approved or reviewed by the FDA. Meaning, if manufacturers can prove a device is similar in use, technology, safety and other metrics with another product already approved, it can go through the simpler 510(k) pathway.
Guidance for modifications
Manufacturers can use the Special 510(k) program when they are modifying a device. The agency advised manufacturers in the Sept. 12 guidance to ensure that the application is submitted by a manufacturer authorized to legally manufacture and market the existing device. The agency also listed several factors to consider before submitting applications, including if the device requires performance data and if there is a well-defined method to evaluate the changes.
If certain criteria are not met, the agency can move the application into the traditional 510(k) pathway for review, according to the guidance document. The FDA said that it intends to review Special 510(k) applications within 30 days of receiving an application, rather than the 90-day window for the traditional pathway.
The FDA's guidance for the Refuse to Accept Policy for 510(k)s was directed to the medical device industry and FDA workers that review applications. The guidance covers how to conduct the administrative review process for applications, which is the first step of the pathway. If there are administrative errors found in applications with the first 15 days of review, the application will not be accepted, according to the guidance.
Seven preliminary questions were outlined for FDA staff conducting the administrative review, including whether the device is eligible for the 510(k) pathway and if clinical studies have been submitted. The guidance also outlined another series of questions regarding administrative aspects of applications, some of which can result in an application not being accepted if it does not meet the requirements of the question.
The guidance for the Abbreviated 510(k) Program and Traditional and Abbreviated 510(k)s outlined best practices for manufacturers that choose to submit applications for the programs.
