News & Announcements
14 November 2020
The FDA clarifies medical face mask sample size requirements for 510 (k) primary market notification requests as it has increased sample size requirements for the provision of medical face masks. We suggest taking the measures below to protect transmission in a smooth and timely manner.

Manufacturers wishing to market a Class I, II, or Class III device intended for human use in the United States and for which pre-market approval (PMA) is not required must file 510 (k) with the FDA, unless The device is exempt from the 510 (k) requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and does not exceed the exemption limits in the chapters on the regulation of device classification.

A 510K is a pre-marketing submission filed with the U.S. Food and Drug Administration to demonstrate that the medical device to be marketed is safe and effective, and that it is substantially equivalent to a device that has been legally marketed. Service providers must compare their device to one or more legally marketed equivalent devices, make and support substantive equivalence claims.

In the past, several manufacturers have successfully completed the submission of 510 (k) pre-marketing notification through the FDA by submitting test reports performed in accordance with ASTM F2100 on a set of five samples, as a minimum, for differential pressure and bacterial filtration efficiency (BFE), and particulate filtration efficiency, for medical face mask products. Recently, an increasing number of 510 (k) review comments have been received stating that a 5-sample test plan may not be enough to support a 510 (k) pre-market submission.
The Food and Drug Administration's requirements are mainly reflected in the following enforcement actions:

- Provide test reports covering three non-consecutive batches of medical face mask samples to validate batch-to-batch performance or explain why this method was not followed.
Single sampling plan according to ISO 2859-1 or ANSI / ASQC Z1.4 requirements.

-Test reports show that medical face mask samples meet ASTM F2100 requirements after an Acceptable Quality Limit (AQL) of 4% to a certain performance class (barrier level)

Based on the expected batch production output of medical face masks, it is impossible that the five-sample test plan would meet this requirement. After reviewing recent FDA 510k implementations, it is recommended to adjust the sample size per lot to at least 32 mask samples per test, as a conservative approach to avoid any interruption or delay in your FDA filing processes. Tests should also be performed in at least three non-consecutive batches to demonstrate production quality and consistency.