Draft 56
- Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation (DRAFT)
- 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)
- Validation of In Vitro Diagnostic Tests for Emerging Pathogens During Public Health Emergencies (DRAFT)
- 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)
- Predetermined Change Control Plans for Medical Device Modifications (DRAFT)
- Premarket Notification Requirements for Dental Curing Light Devices (DRAFT)
- Premarket Notification Requirements for Dental Composite Resin Devices (DRAFT)
- 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)
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Policy for Laboratory Tests Used in Response to Chemical, Biological, Radiological, or Nuclear Public Health Emergencies (DRAFT)
- Enforcement Policies for Unauthorized Diagnostic Tests During Public Health Emergencies (DRAFT)
- Animal Testing Recommendations for Dental Bone Grafting Materials (DRAFT)
- Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)
- Evaluation of Thermal Effects from Medical Devices on Human Tissue (DRAFT)
- Cybersecurity Requirements for Connected Medical Devices with Software (DRAFT)
- Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (DRAFT)
- Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT)
- Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (DRAFT)
- Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making (DRAFT)
- Translation of Non-English Good Laboratory Practice (GLP) Study Reports (DRAFT)
- Development of Products for Prevention and Treatment of Acute and Chronic Graft-Versus-Host Disease (DRAFT)
- Non-Clinical Testing Recommendations for Weight Loss and Obesity Treatment Devices (DRAFT)
- Clinical Study Design and Benefit-Risk Considerations for Weight Loss Medical Devices (DRAFT)
- When Clinical Data is Needed to Support Substantial Equivalence for 510k Submissions (DRAFT)
- Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k (DRAFT)
- Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)
- Patient-Matched Orthopedic Surgical Guides: Testing, Documentation and Safety Requirements (DRAFT)
- Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407 (DRAFT)
- Technical Considerations for Photobiomodulation Devices in 510k Submissions (DRAFT)
- Human Factors Information Needed in Medical Device Marketing Submissions (DRAFT)
- Ethical Considerations for Clinical Investigations of Medical Products in Children (DRAFT)
- Computer Software Assurance for Production and Quality System Software (DRAFT)
- Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices (DRAFT)
- Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies (DRAFT)
- In Vitro Testing and Labeling for Oral Drug Products Administered via Enteral Feeding Tubes (DRAFT)
- Implementation of ICH Q12 Tools and Enablers for Post-Approval CMC Changes in Drug Products and Combination Products (DRAFT)
- Reliability Requirements for Emergency-Use Auto-Injectors (DRAFT)
- Safety Considerations for Flow Restrictors in Oral Liquid Drug Products to Prevent Accidental Ingestion by Children (DRAFT)
- Bridging Strategies for Drug-Device and Biologic-Device Combination Products (DRAFT)
- Standards for Drug Supply Chain Transaction Information, History and Statements (DRAFT)
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (DRAFT)
- List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
- Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices (DRAFT)
- Postapproval Changes to Combination Products: Marketing Submission Requirements (DRAFT)
- Exculpatory Language in Informed Consent Documents for Clinical Research (DRAFT)
- Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
- Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests (DRAFT)