Administrative / Procedural 55
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
- Third Party Review Program for Medical Device 510k and Emergency Use Authorization Reviews
- Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
- Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)
- Medical Device Development Tools (MDDT) Qualification Program
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Risk-Based Monitoring of Clinical Investigations
- De Novo Classification Request User Fees and Refund Policies
- De Novo Classification Request Review Process and Performance Goals
- Clinical Decision Support Software Functions: Device vs Non-Device Classification
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Procedures for Supervisory Review, Appeals, and Dispute Resolution for Medical Device Decisions
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Recognition and Withdrawal Process for Voluntary Consensus Standards
- Uniform Inspection Process and Communications for Medical Device Establishments
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Medical Device User Fee Small Business Qualification and Certification Process
- Medical Product Communications That Are Consistent With FDA-Required Labeling
- Health Care Economic Information Communications to Payors for Medical Devices
- Standards for Drug Supply Chain Transaction Information, History and Statements (DRAFT)
- Medical Device Accessories: Classification and Risk-Based Approach
- Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Use of Electronic Informed Consent in Clinical Investigations
- Meetings with the Office of Orphan Products Development: Procedures and Best Practices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
- Electronic Source Data in Clinical Investigations
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- Adverse Event Reporting to IRBs Under FDA-Regulated Research
- Container and Closure System Integrity Testing as an Alternative to Sterility Testing for Stability Protocols
- Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
- Electronic Distribution of Product Information and Safety Communications
- Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests (DRAFT)
- Civil Penalties for Electronic Product Radiation Control Violations
- Pharmacogenomic Data Submissions in Drug Development and Biomarker Classification
- Electronic Records and Electronic Signatures - Scope and Application
- Day-100 Meetings for PMA Applications: Procedures and Implementation
- Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence
- Direct Final Rulemaking Procedures and Implementation Process
- Maintaining Independence of Industry-Supported Scientific and Educational Activities