DO N95 RESPIRATORS NEED 510(K) SUBMISSION?
N95 respirators and 510(k) submission?
Exporting products to the USA requires some fundamental principles especially PPE such as N95 respirators. One of the requirements is 510(k) submission. Nevertheless, it is not mandatory under some circumstances. In this article, we will brief on you what 510(k) submission is, who needs 510(k) submission, and when it is required.
What is 510(k) submission?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that 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
Who needs 510(k) submission?
The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.
The following four categories of parties must submit a 510(k) to the FDA:
- Domestic manufacturers introducing a device to the U.S. market;
- Specification developers introducing a device to the U.S. market;
- Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
- Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.
N95 respirators are facial protective devices used to protect the wearer from harmful airborne particles. They are regulated by the National Institute for Occupational Safety and Health (NIOSH) which is part of the Centers for Disease Control and Prevention (CDC). These respirators require NIOSH certification.
N95 respirators intended for use in industrial settings such as construction sites or factories to protect workers from dust and debris are not regulated by the FDA. However, N95 respirators that are intended for medical use (e.g. use in healthcare facilities) are regulated by FDA as well as NIOSH. These N95 respirators are class II medical devices but are exempt from the 510(k) premarket notification if the respirator:
- is not intended to prevent specific diseases or infections
- is not labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity.
- does not contain coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).
Masks Not Intended for Medical Purposes
If the masks are not intended for medical use e.g. the masks are for general purpose or industrial use, then the products are not regulated by FDA. Such masks should not be labeled with any claims suggesting the masks offer protection against disease. US Customs recently advised import filers to disclaim or not transmit the entry data to FDA when filing the entries for those products.
When a 510(k) is Required?
A 510(k) is required when:
- Unless exempt, introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976, a 510(k) is required.
- There is a change or modification to a legally marketed device and that change could significantly affect its safety or effectiveness. The burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device. Any modifications must be made in accordance with the Quality System regulation, 21 CFR 820, and recorded in the device master record and change control records. It is recommended that the justification for submitting or not submitting a new 510(k) be recorded in the change control records.A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different intended use. See Is a new 510(k) required for a modification to the device? for additional information.
- FDA website
- FDA specialist