December 23, 2020
The December 23, 2020 online edition of MedTech Intelligence features A New Approach to the FDA’s Special 510(k) Program written by StarFish Medical Senior QA/RA Specialist Tara Lysechko. Subheaded “The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device,” the article reviews and summarizes the implications for medical device developers.
“In an effort to modernize the 510(k) Program, the FDA has recently issued four final guidances on the Special 510(k) Program, the Abbreviated 510(k) Program, the format for Traditional and Abbreviated 510(k)s, and the Refuse to Accept Policy for 510(k)s. The new guidance documents for the Special and Abbreviated 510(k) Programs supersede ‘The New 510(k) Paradigm’.”
“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”. FDA recommends that manufacturers use a risk-based assessment approach to determine whether a new 510(k) is likely required, as outlined in FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device”. Once the determination has been made that a new 510(k) is likely required, the manufacturer can engage in the decision-making process to establish whether the change is appropriate for review under the Special 510(k) Program.”
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.