FDA MQSA Delegation of Authority | Secretary Shalala to FDA Commissioner (63 FR 9555, 1998)

Overview

Published February 25, 1998 (Federal Register Vol. 63, No. 37, page 9555), this 1-page notice is a direct delegation of authority from Secretary of Health and Human Services Donna E. Shalala to the Commissioner of Food and Drugs, effective upon the Secretary's signature on February 11, 1998. The delegation conveys the Secretary's full authorities under Title III, Section 354 of the Public Health Service Act (42 U.S.C. 263b), the statutory foundation of the entire MQSA program, covering facility certification, accreditation body oversight, quality standards, annual inspection requirements, and inspection fee assessment and collection. The notice supersedes the original MQSA delegation issued June 1, 1993 by the Acting Assistant Secretary for Health, titled 'Delegation of Authority for Section 354 of the Public Health Service Act, as amended by Public Law 102-539, the Mammography Quality Standards Act of 1992.' That 1993 delegation was the foundational act that first authorized FDA to implement MQSA, enabling the agency to develop 21 CFR Part 900, begin accrediting accreditation bodies, and commence the national inspection program that enrolled its first facilities in January 1995. By the time this 1998 delegation was issued, FDA had been operating under MQSA authority for nearly five years and had conducted inspections of approximately 10,000 facilities nationally. The 1998 delegation resolves any formal question about the adequacy of the 1993 acting-official delegation by issuing a direct Secretary-level delegation and affirmatively ratifying all prior FDA actions taken under the earlier authority.

Key Contents

How This Applies to Your Practice

The delegation documented in this notice is the administrative foundation under which every MQSA action FDA has taken since 1993 derives its authority. The chain is: Secretary of HHS → Commissioner of Food and Drugs (via this delegation) → CDRH → OCER/DMQRP → authorized inspectors and States as Certifier (SAC) programs. Every element of the MQSA compliance framework that MammoComply users navigate (21 CFR Part 900 quality standards, annual inspection authority, Level 1 and Level 2 finding procedures, accreditation body oversight, certification decisions, and fee assessment) flows through this delegation chain. Without a valid Secretarial delegation, the Commissioner's exercise of MQSA powers would lack statutory grounding. The ratification clause is directly relevant to facilities with long compliance histories. All inspection findings, certification decisions, and fee assessments issued by FDA between June 1993 and February 1998 were retroactively affirmed by Secretary Shalala under this notice. For MammoComply users reviewing historical inspection records (particularly facilities whose compliance documentation spans the 1995–1998 period when the program was scaling from 4,900 to 10,000 annual inspections), this ratification confirms that those records reflect validly authorized agency actions. Any legal or compliance analysis involving FDA's MQSA jurisdiction should start with this delegation and the 1993 delegation it supersedes.