The U.S. Food and Drug Administration (FDA) has clarified the requirements for 510(k), a premarket submission that demonstrates a medical device is safe and effective before it is marketed. The clarification has increased the sample size requirements for medical face masks.
To market Class I, II, or III medical devices for human use in the U.S., the manufacturer must submit a 510(k) to the FDA. Exemptions are products that:
• Require a Premarket Approval (PMA) application
• Are exempt from 510(k) requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and do not exceed the limitation of exemptions in the device classification regulation chapters (e.g. 21 CFR 862.9, 21 CFR 864.9)
510(k) demonstrates that a medical device is safe, effective, and is substantially equivalent to a legally marketed device (section 513(i)(1)(A) FD&C Act). To achieve this, the manufacturer must compare their product with one or more similar legally marketed devices, with supported substantial equivalence claims.
Manufacturers of medical face mass have often successfully completed their 510(k) submission by presenting test reports conducted against ASTM F2100 on a batch of five or more samples – showing Differential Pressure, Bacterial Filtration Efficiency (BFE), and Particle Filtration Efficiency.
Recent review comments on 510(k) submissions now suggest that five samples is insufficient. This is because of the following FDA enforcements:
1. The provision of test reports covering three non-consecutive batches of medical face mask samples to validate lot-to-lot performance or an explanation of why that method was not followed
2. A single sampling plan according to the requirements of ISO 2859-1 or ANSI/ASQC Z1.4
3. Test reports showing that the medical face mask samples satisfy the requirements of ASTM F2100 following an acceptable quality limit (AQL) of 4% to a specific performance class (barrier level)
SGS is now recommending a minimum of at least 32 mask samples per test and these tests should also be carried out on at least three non-consecutive batches to demonstrate quality and consistency.
By adopting this conservative approach to 510(k) submission, the manufacturer can mitigate the risk of delays.
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