FDA Comprehensive List of Guidance Documents | 75 FR 48180 (2010)

Overview

Published under FDA's Good Guidance Practices (GGPs) regulation at 21 CFR 10.115, first codified at 65 FR 56468 (September 19, 2000), effective October 19, 2000, this 54-page Federal Register notice fulfills FDA's obligation to inform the public of the existence, availability, and legal effect of all active guidance documents across the agency. FDA adopted a new consolidated format for this publication beginning with the 2010 notice, intended to increase timeliness and usability compared to prior years. The list reflects FDA's online guidance database as captured from each Center's or Office's website as of April 22, 2010; FDA updates that live database daily, so the published list is a point-in-time snapshot that must be read as such. The document is organized by issuing Center and Office: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC). The CDRH section (the primary reference for mammography facilities) is further subdivided by organizational unit: Cross-Center guidance, OC (Office of the Center Director) guidance, OCER (Office of Communication, Education and Radiation Programs) guidance including DMQRP (Division of Mammography Quality and Radiation Programs), ODE (Office of Device Evaluation), and OIVD (Office of In Vitro Diagnostics). A notable feature of the 2010 CDRH section: CDRH reported no withdrawn guidance documents in the preceding five years, meaning every CDRH guidance document listed was actively operative as of April 22, 2010. Docket No. FDA-1998-N-0050 (formerly 1998N-0046) remains open for public comments on any guidance listed.

Key Contents

How This Applies to Your Practice

The four OCER/DMQRP guidance documents listed in this 2010 comprehensive notice represent the complete operative MQSA guidance library as of April 22, 2010, and each directly informs MammoComply's compliance framework. Policy Guidance Help System (PGHS) additions #12 (Doc #1623, February 2007) and the draft #13 (Doc #1695, October 2009) contain the FAQ-style policy interpretations that MQSA inspectors use to apply 21 CFR Part 900 to specific facility situations; these are the documents an inspector cites when a written requirement is ambiguous. Doc #6400 (Compliance Guidance: Preparing For MQSA Inspections) is the direct predecessor to the MQSA Inspection Manual in the MammoLibrary, establishing the inspection framework that was in use from 2001 through the 2024 Final Rule transition. Doc #6409 governs medical physicist qualification requirements and facility survey standards, the thresholds that MammoComply's physicist credential module tracks. The FFDM-specific guidance documents (Doc #1616, #1617) reflect the transition to digital mammography that was underway in 2010 and that is now complete; the 510(k) premarket notification pathway these documents describe was the regulatory route for DBT systems later reviewed under the separate DBT reclassification rulemaking. The absence of any CDRH withdrawn guidance documents as of April 22, 2010 confirms that the entire CDRH guidance library was actively operative at that point, meaning any CDRH guidance document referenced in pre-2010 facility compliance documentation, QC manuals, or physicist annual survey reports was then current. Subsequent changes (including the 2024 Final Rule) have superseded portions of that library; current mammography guidance should be verified at fda.gov rather than against this 2010 snapshot.