FDA COVID-19 Guidance Documents: Notice of Availability — Including MQSA Enforcement Policy
86 FR 106 · Dockets FDA-2020-D-1825 & FDA-2020-D-1138 · January 4, 2021
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- Lauren K. Roth, Acting Principal Associate Commissioner for Policy, FDA
- Edition
- 86 FR 106, 2021
- Pages
- 4 pages
- Added to library
- Added August 20, 2026
Overview
This four-page Federal Register notice is a consolidated NOA announcing the availability of four COVID-19-related FDA guidance documents implemented without prior public comment under section 701(h)(1)(C) of the FD&C Act and § 10.115(g)(2). The four guidances are: (1) Investigational COVID-19 Convalescent Plasma — Updated November 2020 (CBER, Docket FDA-2020-D-1825); (2) Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J — Revised November 2020 (CDRH, Docket FDA-2020-D-1138); (3) Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators — November 2020 (CDRH, Docket FDA-2020-D-1138); and (4) Enforcement Policy for the Quality Standards of the MQSA During the COVID-19 PHE — December 2020 (CDRH, Docket FDA-2020-D-1138; 21 CFR Part 900). All four guidances represent FDA's current thinking but are non-binding. The consolidated NOA was signed December 29, 2020 by Lauren K. Roth, Acting Principal Associate Commissioner for Policy, and published January 4, 2021.
Key Contents
-NOA covers four COVID-19 PHE guidance documents implemented immediately without prior public comment (FD&C Act § 701(h)(1)(C); 21 CFR § 10.115(g)(2))
-MQSA-specific guidance (Table 1, Docket FDA-2020-D-1138, CDRH):
Title: 'Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act [MQSA] During the COVID-19 Public Health Emergency (December 2020)'
Citation: 21 CFR Part 900 | OMB Control No.: 0910-0309 | Document No. for single-copy requests: 20047
-PHE PRA waiver documentation required from MQSA facilities under this guidance:
• Document the time period the facility was temporarily closed; present at the MQSA inspection
• Document circumstances re: lack of medical physicist survey within 14 months of the last annual survey
• Provide information on inability to meet survey timeframes described in the guidance
• Provide documentation of the dates and events that led to noncompliance
• Confirm that facility will ensure compliance as soon as possible after COVID-19 restrictions are lifted
-Other CDRH guidance in this NOA:
• Section 506J device manufacturing discontinuance/interruption notification (revised, Nov 2020) — OMB 0910-0491/0910-0625
• N95/filtering facepiece respirator single-user reuse via dry heat bioburden reduction — OMB 0910-0595
-CBER guidance (separate docket FDA-2020-D-1825): Investigational COVID-19 Convalescent Plasma — updated November 2020 — OMB 0910-0014/0910-0116; Form FDA 3926 (OMB 0910-0814)
-FDA COVID-19 guidance portal: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders
-For CDRH single copies: CDRH-Guidance@fda.hhs.gov — include document number 20047 and full guidance title
-Contact: Erica Takai, CDRH, FDA, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002; 301-796-6353
How This Applies to Your Practice
The MQSA enforcement policy guidance referenced in this NOA directly affected every mammography facility during the COVID-19 PHE. Facilities that closed temporarily, were unable to complete medical physicist surveys within the required 14-month window, or otherwise fell out of MQSA compliance due to COVID-19 restrictions needed to document those circumstances and present them at their next MQSA inspection. MammoComply users whose facilities experienced any COVID-era compliance gaps should verify that supporting documentation (closure dates, physicist survey delays, corrective action timelines) was retained and is still accessible in the event of a future inspection or AMR. This NOA also confirms that all four guidances remain subject to public comment despite having been implemented immediately — FDA's enforcement discretion posture during the PHE does not grant permanent relief.
Practitioner Implications
Facilities that experienced COVID-19-related MQSA compliance disruptions (temporary closure, missed medical physicist surveys, delayed inspections) should confirm that documentation required under the December 2020 MQSA enforcement policy guidance was created and retained. Inspectors may still reference this guidance when reviewing a facility's compliance history covering 2020-2021. The guidance itself is available via FDA CDRH guidance portal (document number 20047) or by emailing CDRH-Guidance@fda.hhs.gov.