Biologics 194
- Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
- Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (DRAFT)
- Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
- Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
- Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- Long-Term Neurodevelopmental Safety Evaluation of Medical Products Used in Neonates
- The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (DRAFT)
- Biocompatibility Testing Standards and Accreditation Requirements in the ASCA Program (DRAFT)
- Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program (DRAFT)
- Chemical Analysis in Medical Device Biocompatibility Assessment (DRAFT)
- Patient Preference Information in Medical Device Development and Benefit-Risk Assessments (DRAFT)
- Voluntary Malfunction Summary Reporting Program for Medical Devices
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
- User Fees for Combination Products and Associated Waivers
- Use-Related Risk Analysis for Drug, Biological, and Combination Products: Determining Human Factors Study Needs (DRAFT)
- Essential Drug Delivery Outputs for Drug Delivery Devices and Combination Products (DRAFT)
- Diversity in Clinical Trials: Enrollment Goals and Action Plans for Underrepresented Racial, Ethnic, Sex and Age Groups (DRAFT)
- Laboratory Developed Tests (LDTs) Enforcement Discretion Policy and Phased Compliance Requirements
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)
- Cybersecurity Requirements for Connected Medical Devices with Software (DRAFT)
- Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT)
- Translation of Non-English Good Laboratory Practice (GLP) Study Reports (DRAFT)
- Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- Development of Products for Prevention and Treatment of Acute and Chronic Graft-Versus-Host Disease (DRAFT)
- Breakthrough Devices Program: Expedited Development and Review Process for Novel Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- When Clinical Data is Needed to Support Substantial Equivalence for 510k Submissions (DRAFT)
- Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k (DRAFT)
- Human Factors Studies and Related Analyses for Combination Products
- Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Content of Premarket Submissions for Device Software Functions
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
- Risk-Based Monitoring of Clinical Investigations
- Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407 (DRAFT)
- Clinical Investigator Disqualification Procedures and Administrative Actions
- References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- User Fees and Refunds for 510k Submissions
- User Fee Requirements and Payment Process for 513(g) Requests for Information
- MDUFA Performance Goals and Processing of 510k Submissions
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- Policy for Device Software Functions and Mobile Medical Applications
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- Clinical Decision Support Software Functions: Criteria for Non-Device Classification and Implementation Requirements
- Ethical Considerations for Clinical Investigations of Medical Products in Children (DRAFT)
- Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision
- Including Older Adults in Cancer Clinical Trials: Design and Conduct Considerations
- Premarket Review Pathways for Combination Products
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- Patient-Reported Outcome Instruments in Medical Device Evaluation
- Histopathology Peer Review in Nonclinical Toxicology Studies
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Acceptance Review for De Novo Classification Requests
- Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies (DRAFT)
- Export Certification Process and Requirements for FDA-Regulated Products
- Unique Device Identifier (UDI) Form and Content Requirements
- Implementation of ICH Q12 Tools and Enablers for Post-Approval CMC Changes in Drug Products and Combination Products (DRAFT)
- Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
- Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
- Testing for Biotin Interference in In Vitro Diagnostic Devices Using Biotin/Avidin Technology
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- Electronic Submission Requirements for Medical Device Submissions
- Uniform Inspection Process and Communications for Medical Device Establishments
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Reliability Requirements for Emergency-Use Auto-Injectors (DRAFT)
- Developing and Labeling Companion Diagnostics for Multiple Oncology Therapeutic Products
- Safety Considerations for Flow Restrictors in Oral Liquid Drug Products to Prevent Accidental Ingestion by Children (DRAFT)
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
- CLIA Waiver Applications for In Vitro Diagnostic Devices - Demonstrating Simplicity and Insignificant Risk of Erroneous Results
- Bridging Strategies for Drug-Device and Biologic-Device Combination Products (DRAFT)
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- Humanitarian Use Device (HUD) Designation Requests: Content and Format
- Benefit-Risk Determinations for Medical Device Premarket Review
- Postmarketing Safety Reporting Requirements for Combination Products
- Technical Specifications for Next Generation Sequencing Data in Antiviral Drug Development
- Unique Device Identification Requirements for Convenience Kits
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- Medical Devices Used in Recovery, Isolation, and Delivery of Regenerative Medicine Advanced Therapies
- Public Warning and Notification of Recalls Under Part 7
- Least Burdensome Principles for Medical Device Regulation
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- Impact of Revised Common Rule on FDA-Regulated Clinical Investigations
- Selection of Package Type Terms and Discard Statements for Injectable Medical Products
- Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
- Medical Device User Fee Small Business Qualification and Certification Process
- Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
- Medical Product Communications That Are Consistent With FDA-Required Labeling
- Health Care Economic Information Communications to Payors for Medical Devices
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
- Use of Next Generation Sequencing in the Diagnosis of Germline Diseases
- Standards for Drug Supply Chain Transaction Information, History and Statements (DRAFT)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- Medical Device Accessories: Classification and Risk-Based Approach
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- Technical Considerations for Additive Manufactured Medical Devices
- IDE Device Categorization for Medicare Coverage: Category A vs Category B Determination
- Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
- Deciding When to Submit a New 510k for Software Changes to Medical Devices
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Design Considerations and Recommendations for Interoperable Medical Devices
- Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- Current Good Manufacturing Practice Requirements for Combination Products
- Use of Electronic Informed Consent in Clinical Investigations
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Adaptive Designs for Medical Device Clinical Studies
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (DRAFT)
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- Meetings with the Office of Orphan Products Development: Procedures and Best Practices
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Recommendations for Labeling Medical Products Without Natural Rubber Latex
- Dual Use Molecular Diagnostic Instruments with FDA-Approved and Non-Approved Functions
- Unique Device Identification System: Implementation and Compliance Requirements
- In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- Considering Whether FDA-Regulated Products Involve Nanotechnology
- Transfer of Clinical Investigation Oversight Between Institutional Review Boards
- Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- Types of Communication During Medical Device Submissions Review
- Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
- Premarket Assessment of Medical Devices for Pediatric Use
- Public Disclosure of Advisory Committee Members' Financial Interests and Waivers
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Design Considerations for Medical Device Pivotal Clinical Studies
- Electronic Source Data in Clinical Investigations
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Radio Frequency Wireless Technology in Medical Devices
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- Exception from Informed Consent Requirements for Emergency Research
- Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices (DRAFT)
- Financial Disclosure Requirements for Clinical Investigators
- Postapproval Changes to Combination Products: Marketing Submission Requirements (DRAFT)
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- Exculpatory Language in Informed Consent Documents for Clinical Research (DRAFT)
- How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs
- Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
- Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- IRB Registration Requirements and Procedures
- Adverse Event Reporting to IRBs Under FDA-Regulated Research
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
- Voting Procedures for Advisory Committee Meetings
- Preparation and Submission of Advisory Committee Briefing Materials for Public Release
- Container and Closure System Integrity Testing as an Alternative to Sterility Testing for Stability Protocols
- Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment
- Bundling Multiple Devices and Multiple Indications in Medical Device Submissions
- Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
- Process for Clinical Investigations Involving Children Requiring Additional Safeguards
- Early Development Considerations for Combination Products
- Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- Establishment and Operation of Clinical Trial Data Monitoring Committees
- Electronic Distribution of Product Information and Safety Communications
- Pharmacogenetic Tests: Premarket Submission Requirements and Performance Validation
- Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests (DRAFT)
- Pharmacogenomic Data Submissions in Drug Development and Biomarker Classification
- Dispute Resolution Process for Combination Product Review Timelines
- Electronic Records and Electronic Signatures - Scope and Application
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Categories of Research Eligible for Expedited IRB Review
- 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
- Export Requirements for Products Not Approved for Sale in the United States
- Reinspection of Firms During Pending Legal Actions
- Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies