FDA immediately exempts 7 medical devices from the 510(k) requirement and proposes to exempt an additional 83 more.
The COVID-19 public health emergency brought about a sudden and unexpected need for personal protective equipment and other medical devices. In response, the Food and Drug Administration (FDA) issued a number of guidance documents that, among other things, waived the premarket notification (510(k)) requirement for the lawful distribution of these devices during the public health emergency.
Now, FDA is permanently exempting seven of these devices (all being types of examination, medical, or surgeon’s gloves (product codes OPC, LZC, OPH, OPA, OIG, LYY, LYZ)) from the 510(k) requirement.
Moreover, the Agency is also proposing to eliminate the requirement for an additional 83 devices. Before it does so, FDA has asked for the public to comment on whether the 510(k) requirement should or should not be permanently waived for some or all of these devices.
A complete list of the types of devices FDA is now considering exempting from the 510(k) requirement is too voluminous to include here. The complete list can be found in the Federal Register notice here. Some examples from this list include devices such as:
- N95 Respirators with Antimicrobial/Antiviral Agents (21 C.F.R. § 878.4040 (OKC));
- N95 Respirators with Antimicrobial/Antiviral Agents for use by the General Public In Public Health Medical Emergencies (21 C.F.R. § 878.4040 (ORW));
- Surgical Masks with Antimicrobial/Antiviral Agents (21 C.F.R. § 878.4040 (OUK));
- Pediatric/Child Facemasks (21 C.F.R. § 878.4040 (OXZ));
- Surgical Isolation Gowns (21 C.F.R. § 878.4040 (FYC));
- Ultraviolet Medical Air Purifiers (21 C.F.R. § 880.6500 (FRA));
- Medical Recirculating Air Purifiers (21 C.F.R. § 880.5045 (FRF));
- Ethylene-Oxide Gas Sterilizers (21 C.F.R. § 880.6860 (FLF));
- Dry Heat Sterilizers (21 C.F.R. § 880.6870 (KMH));
- Medical Image Analyzers (21 C.F.R. § 892.2070 (MYN));
- Medical Device Cleaners (21 C.F.R. § 880.6692 (MDZ)); and
- Home Use, Minimal Support Ventilators (21 C.F.R. § 868.5895 (NQY)).
FDA’s proposal should be viewed as welcome news for companies that are presently distributing these listed products under an EUA or enforcement discretion without the benefit of a 510(k) clearance. The current distribution of the COVID-19 vaccine presages the day when the public health emergency will be declared to be over. When this day comes, companies that are distributing these under an EUA or enforcement discretion will be required to cease distribution unless they have submitted for and received their own 510(k) clearances. However, an FDA determination that their devices are exempt from the 510(k) requirement before this day comes would undoubtedly have a significant and positive impact on their ability to continue to distribute after the public health emergency is declared to be over.
Our experience from working closely with our clients before and during the current public health emergency has made it clear to us that an expensive and lengthy 510(k) process is not always necessary to assure the safe and effective use of many, if not all, of the devices being proposed for the exemption.
Lobbying for 510(k) exemption of relevant devices of interest to you could lead to significantly reducing your regulatory burden and costs in bringing devices to the U.S. market. If you think you are affected and want to submit comments, we can help. We are available to assist you with the formulation of points in favor of 510(k) exemption and help with the filing procedures.
As always, please let us know if you have any questions.
ATW Medical Device Group:
Neil O’Flaherty – Neil@amintalait.com
Evan Phelps – Evan@amintalati.com
Shelly Garg – Shelly@amintalati.com