Investigation & Enforcement 24
- Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT)
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- Public Warning and Notification of Recalls Under Part 7
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Current Good Manufacturing Practice Requirements for Combination Products
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- Civil Penalties for Electronic Product Radiation Control Violations
- X-ray Tube Housing Assembly Reloading Facilities: Registration, Listing and Inspection Requirements
- Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
- Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers
- Electronic Records and Electronic Signatures - Scope and Application
- Enforcement Policy for X-Ray Assembly Report Filing Requirements
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- Model and Serial Number Labeling Requirements for X-Ray System Components
- Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- Enforcement Policy for Positive-Beam Limitation Requirements in Diagnostic X-Ray Systems
- Reinspection of Firms During Pending Legal Actions
- X-ray Field Size Control Requirements for Fluoroscopic and Spot-Film Systems