Delegations of Authority and Organization: CDRH Authority to Enforce MQSA (FR Doc. 95-22578)
60 FR 47267 · 21 CFR Part 5, §5.85 · Effective September 12, 1995
Last Reviewed: August 21, 2026
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- William B. Schultz, Deputy Commissioner for Policy, FDA
- Edition
- Final Rule — 60 FR 47267, 1995
- Pages
- 3 pages
- Added to library
- Added August 21, 2026
Overview
This three-page Federal Register final rule (Vol. 60, No. 176, September 12, 1995) amends 21 CFR §5.85 to comprehensively redelegate to CDRH officials the Commissioner of Food and Drugs' authority to implement the MQSA. The MQSA delegated broad authority to the Secretary of Health and Human Services, who delegated to the Commissioner; the Commissioner had previously redelegated certificate-issuance authority in 1994 (59 FR 35849, July 14, 1994). This 1995 rule expands that redelegation to cover all major MQSA functions enumerated in section 354 of the Public Health Service Act (42 U.S.C. 263b). The delegations apply to three specific positions within CDRH, with sanctions, certificate suspension/revocation, and certain other authorities reserved exclusively to the Director and Deputy Director for Regulations and Policy. Further redelegation of the delegated authorities is expressly prohibited. Signed by William B. Schultz, Deputy Commissioner for Policy, September 1, 1995.
Key Contents
-Regulatory action: Final rule | FR Doc. 95-22578 | 21 CFR Part 5, §5.85
-Published: Federal Register Vol. 60, No. 176 (September 12, 1995), pages 47267–47269
-Effective date: September 12, 1995 (immediate effect)
-Signed: William B. Schultz, Deputy Commissioner for Policy, September 1, 1995
-Contacts: Richard E. Gross, CDRH (HFZ-200), 301-443-2845 | Ellen R. Rawlings, Div. of Management Systems and Policy (HFA-340), 301-443-4976
-MQSA authority chain: MQSA (Pub. L. 102-539) → Secretary of HHS → Commissioner of Food and Drugs (delegated June 10, 1993, 58 FR 32543) → CDRH officials (this rule)
-Three officials receiving delegated MQSA authority:
1. Director and Deputy Director for Regulations and Policy, CDRH
2. Director, Office of Health and Industry Programs (OHIP), CDRH
3. Director, Division of Mammography Quality and Radiation Programs, OHIP, CDRH
-Authority delegated by function (21 CFR §5.85(a) to (m)):
(a) Issue, renew, and extend certificates: all three officials
(b) Accept applications for certificates: all three officials
(c) Approve accreditation bodies: Director/Deputy Director and OHIP Director only
(d) Ensure accreditation bodies provide satisfactory assurances of compliance: all three officials
(e) Promulgate regulations to withdraw accreditation body approval: Director, CDRH only
(f) Determine accreditation standards for a facility: all three officials
(g) Ensure accreditation bodies make on-site visits; determine whether other measures are appropriate: all three officials
(h) Evaluate annually the performance of each approved accreditation body: all three officials
(i) Determine compliance of certified facilities through inspections: all three officials
(j) Impose sanctions under §354(h)(1) and (h)(2): Director and Deputy Director for Regulations and Policy ONLY
(k) Suspend or revoke individual facility certificates under §354(i)(1) and (i)(2)(A): Director and Deputy Director for Regulations and Policy ONLY
(l) Compile and make available to physicians and the public information useful in evaluating facility performance: Director and Deputy Director for Regulations and Policy ONLY
(m) Authorize States to carry out certification requirements and implement quality standards: Director/Deputy Director and OHIP Director; Director CDRH may withdraw state authority
-Express prohibition: Further redelegation of these authorities is NOT authorized
-Authority exercisable by acting or temporary incumbents of each position
-Statutory basis: Section 354 of the Public Health Service Act (42 U.S.C. 263b)
How This Applies to Your Practice
This rule is the legal bedrock of every MQSA enforcement action taken by FDA. When an MQSA inspector conducts a facility inspection, when FDA imposes a Level I or Level II sanction, when a certificate is suspended or revoked, when an accreditation body is evaluated or withdrawn, all of those actions derive their authority from the delegations established and codified in 21 CFR §5.85 by this 1995 rule. Facilities and compliance professionals who receive enforcement correspondence from FDA should understand which officials are authorized to take which actions. Critically, sanctions and certificate suspension/revocation are reserved exclusively to the Director and Deputy Director for Regulations and Policy, CDRH; these actions cannot be taken by OHIP or the Division of Mammography Quality and Radiation Programs.
Practitioner Implications
Any MQSA enforcement action (inspection finding, sanction letter, certificate suspension, or revocation) must originate from an official holding one of the three positions named in 21 CFR §5.85. Facilities receiving enforcement correspondence should confirm the signatory's role against this delegation structure. Facilities operating in states with FDA-approved state certification programs (§5.85(m)) should note that state authority is derivative of and subordinate to the federal delegation structure established here. Further redelegation within CDRH is prohibited, so no sub-delegated authority exists below the three named positions.
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