March 10, 2023
The US FDA has issued a number of updates, including revised emergency use authorizations (EUA) for surgical masks, extended Medical Device Single Audit Program (MDSAP) temporary audit measures, software algorithm device to assist users in digital pathology as Class II IVDs, and updated guidance on radiation-emitting electronic health products.
COVID-19: revised EUA for surgical masks
The US FDA revised the umbrella EUA for disposable, single-use surgical masks to limit its scope to only those surgical masks listed in Appendix A as of March 6, 2023. The agency will no longer be adding surgical mask models to Appendix A and new surgical masks will be subject to the traditional premarket pathways.
COVID-19: MDSAP APMs extend temporary audit measures until June 2023
The MDSAP Assessment Program Managers (APMs) issued Transmittal No. AO 2023-01 extending the alternative on-site audit arrangements detailed in Transmittal No. AO-2020-10 until June 30, 2023. These measures are strictly limited to situations where on-site audits cannot be conducted due to travel restrictions, quarantine orders, or social distancing requirements in response to the COVID-19 pandemic.
Final order identifying software algorithm device to assist users in digital pathology as Class II IVD
The FDA issued a final order identifying software algorithm devices, intended to assist users in determining a pathology diagnosis, as a Class II IVD subject to premarket notification requirements and special controls, effective February 2, 2023. This classification is codified under the newly added 21 CFR 864.3750 with special controls covering certain design verification and validation (e.g., device descriptions, analytical studies, and clinical studies) and labeling (e.g., performance information and certain limitations).
FDA updates certain guidance documents on radiation-emitting electronic health products
Following the issuance of the final rule which streamlines and clarifies the radiological health regulations as of February 21, 2023, the FDA updated the following guidance documents to align with the amended regulations:
- Medical X-Ray Imaging Devices Conformance with IEC Standards
- Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
- Assembler’s Guide to Diagnostic X-Ray Equipment
- Performance Standard for Diagnostic X-Ray Systems and their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide
- Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)
Emergo by UL will post updates as they become available.
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