Media Coverage

MTI: A New Approach to the FDA’s Special 510(k) Program

December 23, 2019

FDA’s Special 510(k) Program


A New Approach to the FDA’s Special 510(k) Program” by Tara Lysechko, StarFish Medical Senior QA/RA Specialist, is featured in the December 23, 2019, online edition of Medtech Intelligence (MTI).

Sub-headed “The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device,” the article provides an overview of the program and describes the three main factors to consider when determining whether a change to an existing device may be appropriate for a Special 510(k).

Lysechko notes, “The significant change to the Special 510(k) Program involves eligibility factors. The old policy focused on whether changes affected either the intended use or altered the fundamental scientific technology of the device. These types of changes would be deemed inappropriate for the Special 510(k) Program and trigger FDA to convert the submission to a Traditional 510(k). Under the new policy, certain changes to the indications for use are permitted, and the focus has shifted to whether the methods to evaluate the change are well-established and whether the results can be sufficiently reviewed in a summary or risk analysis format.”

In addition to examples of scenarios in which the data to support the SE determination is not appropriate for a Special 510(k), the article includes this advice: “It is important to note that not all changes to existing medical devices require a new 510(k). According to 21 CFR 807.81(a)(3), changes that require premarket notification are those that “could significantly affect the safety or effectiveness of the device” or “a major change or modification in the intended use of the device”.   Read the complete A New Approach to the FDA’s Special 510(k) Program article here.

Tara Lysechko is a senior QA/RA specialist at StarFish Medical. Lysechko has 11 years of natural health product industry experience in Regulatory Affairs, including seven years consulting to start-up companies. At StarFish Medical, Lysechko provides quality assurance and regulatory support for the design, development and manufacture of innovative medical devices. Previous experience includes working for biotechnology companies developing novel medicines. Lysechko holds a Ph.D. in Immunology from the University of Alberta.

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