SGS Recommends Changes to Test Plan for FDA 510(k) Premarket Submissions for Medical Face Masks

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

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)

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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

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
  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.

SGS Medical PPE Services

SGS offers a full range of
services to help manufacturers and suppliers of medical PPE deliver high quality,
safe, and compliant products to markets around the world. Learn more about SGS
Medical PPE

SGS SafeGuardS keep you up to date with the
latest news and developments in the consumer goods industry. Read the full US
FDA Clarifies Medical Face Mask Sample Size Requirements For 510(k) Premarket
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For further information contact:

Birkoff Chen
Operations Manager
Tel: +852 2765 3561



LinkedIn: sgs-consumer-goods-&-retail

About SGS

SGS is the world’s leading inspection, verification, testing and
certification company. SGS is recognized as the global benchmark for quality
and integrity. With more than 89,000 employees, SGS operates a network of over
2,600 offices and laboratories around the world.

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