- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff
- Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff
- Medical Device Accessories - Describing Accessories and Classification Pathway for New Accessory Types - Guidance for Industry and Food and Drug Administration Staff
- Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) - Guidance for Industry and Food and Drug Administration Staff
- Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug Administration Staff
- Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes - Guidance for Industry and Food and Drug Administration Staff
- Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- Medical Device Reporting for Manufacturers - Guidance for Industry and Food and Drug Administration Staff
- Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Guidance for Industry and Food and Drug Administration Staff
- Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Guidance for Industry and Food and Drug Administration Staff
- Collection of Race and Ethnicity Data in Clinical Trials - Guidance for Industry and FDA Staff
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Guidance for Industry and Food and Drug Administration Staff
- Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Guidance for Industry and Food and Drug Administration Staff
- Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and Food and Drug Administration Staff
- Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Software as a Medical Device (SaMD): Clinical Evaluation - Draft Guidance
Want to know more about other recently released FDA Medical Device Guidance Documents? Please see my previous blog posts:
New FDA Guidance Documents for the 2nd Quarter 2016
New FDA Guidance Documents for the 1st Quarter 2016
