Face masks used for protection during the Coronavirus pandemic, and in any healthcare setting, belong to the product category of ‘disposable medical PPE. We can generally categorize PPE face masks 3 ways:
1.Surgical face mask (medical face mask) – vary from 3 to 5 ply thickness
2.N95 Respirators – vary based on oil-resistance and filtration percentage
3.Regulations common to both Medical Face Masks and Respirators
You may find the FDA’s Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency useful.
This outlines some of the policy changes they have implemented during the crisis, including the relaxation of some regulations you will see in this section.
These regulations will usually be in place for importers who are importing face masks from China to the USA, or those sourced from other foreign countries, too.
FDA 21 CFR regulation for surgical masks & respirators
Surgical masks and respirators are FDA classified under 21 CFR 878.4040 which lays out requirements for importers including:
- Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,
- Registration and Listing requirements in 21 CFR 807,
- Quality System Regulation requirements in 21 CFR 820,
- reports or corrections and removals in 21 CFR Part 806,
- Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.
The following will be made clear in order to import, distribute, and use surgical masks and respirators
- Analysis and Non-clinical testing
- Usability performance
- Labeling requirements
- Warning and precautions
510(k) premarket FDA clearance
Surgical mask manufacturers or importers are required to submit a 510(k) premarket notification to gain the FDA’s clearance to import and sell the products in the USA.
There is a 90 lead time between submitting the 510(k) and being able to place the products on the market.
A 510(k) will include the following (read the format from the FDA here):
- (1) Medical Device User Fee Cover Sheet (Form FDA 3601)
- (2) Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514)
- (3) 510(k) Cover Letter
- (4) Indications for Use Statement (Form FDA 3881)
- (5) 510(k) Summary or 510(k) Statement
- (6) Truthful and Accuracy Statement
- (7) Class III Summary and Certification
- (8) Financial Certification or Disclosure Statement
- (9) Declarations of Conformity and Summary Reports
- (10) Device Description
- (11) Executive Summary/Predicate Comparison
- (12) Substantial Equivalence Discussion
- (13) Proposed Labeling
- (14) Sterilization and Shelf Life
- (15) Biocompatibility
- (16) Software
- (17) Electromagnetic Compatibility and Electrical Safety
- (18) Performance Testing – Bench
- (19) Performance Testing – Animal
- (20) Performance Testing – Clinical
If any sections are not applicable, they will be included in the document, but can be denoted as ‘N/A.’
In order to make the submission, the mask manufacturer or importer will also need to create an online account with the FDA in order to do so.
Planning on importing face masks to the USA, but unsure about it, or need help?
We’re helping clients globally undertake due diligence on PPE suppliers, inspecting products before shipping, and much more. If you’re stuck, perhaps we can help!