US FDA Clarifies Medical Face Mask Sample Size Requirements for 510(k) Premarket Notification Submissions

Manufacturers wanting to market a Class I, II, or III device intended for human use in the US, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to the US Food and Drug Administration (FDA), unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in the device classification regulation chapters (e.g. 21 CFR 862.9, 21 CFR 864.9).

A 510(K) is a premarket submission made to the US FDA to demonstrate that the medical device to be marketed is safe and effective, that it is substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.

In the past, many manufacturers have successfully completed their 510(k) Premarket Notification submission through the US FDA by presenting test reports conducted according to ASTM F2100 on a batch of five samples, minimum, for Differential Pressure, Bacterial Filtration Efficiency (BFE), and Particle Filtration Efficiency, for medical face mask products. Recently, an increasing number of 510(k) review comments have been received showing that the 5-sample test plan may no longer be sufficient to support the 510(k) premarket submission.

The FDA requirements are mainly reflected in the following 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)

Based on the expected batch production output of medical face masks, it is impossible for the five-sample test plan to meet this requirement. Following a review of recent FDA 510(k) applications, it is recommended that the sample size for each batch be adjusted to at least 32 mask samples per test, as a conservative approach to avoid any interruption or delay in your FDA submissions. Tests should also be carried out on at least three non-consecutive batches in order to illustrate the quality and consistency of production.

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