CDRHNew - News and Updates
October 5, 2022
- Medical Device User Fee Amendments (MDUFA) | FDA
- Device Registration and Listing | FDA
- User Fees and Refunds for De Novo Classification Requests
- User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
- User Fees and Refunds for Premarket Notification Submissions (510(k)s)
- User Fees and Refunds for 513(g) Requests for Information
- Aptima CMV Quant Assay (Hologic, Inc.) - P210029
- At-Home OTC COVID-19 Diagnostic Tests (Extended Expiration Date for QuickVue At-Home OTC COVID-19 Test)
- Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)
- MQSA National Statistics (Updated)
October 4, 2022
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated)
- Transcript, Presentation, and Slides: COVID-19 and and Monkeypox Test Development and Validation Virtual Town Hall Series - September 28, 2022
October 3, 2022
- IC-8 Apthera Intraocular Lens (AcuFocus, Inc.) - P210005
- Updated Emergency Use Authorization
- eCopy Medical Device Submissions (Updated)
- Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
- Voluntary eSTAR Program (Updated)
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
September 30, 2022
- LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure
- Medical Devices and Radiation-Emitting Products Committee Vacancies (Updated)
- Roster for the Ophthalmic Devices Panel (Updated)
- Roster of the Immunology Devices Panel (Updated)
- Roster of the Medical Devices Dispute Resolution Panel (Updated)
- Roster of the Anesthesiology and Respiratory Therapy Devices Panel (Updated)
September 29, 2022
- Virtual Town Hall Series - Test Development and Validation (COVID-19 and Monkeypox) - September 28, 2022 (Updated)
- Joint Public Workshops - Medical Devices for Opioid Use
- NeVa VS - H210004 (Versalio)
- Oncomine Dx Target Test - P160045/S035
- Revised Emergency Use Authorization
- Device Software Functions Including Mobile Medical Applications (Updated)
- Examples of Device Software Functions the FDA Regulates (Updated)
- Examples of Software Functions That Are NOT Medical Devices (Updated)
- Examples of Software Functions for Which the FDA Will Exercise Enforcement Discretion (Updated)
- How to Determine if Your Product is a Medical Device (Updated)
- Digital Health Terms (Updated)
- Ask a Question About Digital Health Regulatory Policies (Updated)
September 28, 2022
- Revised Emergency Use Authorization
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices
- Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration - 10/24/2022 (Updated)
- CDRH Learn: Specialty Technical Topics (Updated)
- Presentation and Transcript: Policy for Monkeypox Tests, Session 2 - September 21, 2022
September 27, 2022
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Guidance for Developers and Food and Drug Administration Staff
- COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Testing for SARS-CoV-2 (Updated)
- COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
- Webinar - Clinical Decision Support Software Final Guidance - October 18, 2022
- Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff
- Digital Health Policy Navigator
- Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (Updated)
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (Updated)
- Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff (Updated)
- Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions (Updated)
- Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff (Updated)
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Federal Register: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Amendment of Notice
- Federal Register: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
- Federal Register: Guidance - Clinical Decision Support Software
September 26, 2022
September 23, 2022
- Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and Institutional Review Boards; Availability
September 22, 2022
- Revoked Emergency Use Authorization
- Revised Emergency Use Authorization
- Virtual Town Hall Series - Test Development and Validation (COVID-19 and Monkeypox) - September 28, 2022
September 21, 2022
- Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff
- eCopy Program for Medical Device Submissions (Updated)
- Tracking Your Premarket Submission's Progress (Progress Tracker) (Updated)
- Office of Product Evaluation and Quality (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220025 added)
September 20, 2022
- Information on Cybersecurity (Updated)
- Medical Device Development Tools (MDDT) (Updated)
September 19, 2022
- Virtual Town Hall Series - Monkeypox Test Development and Validation (Updated)
- CDRH Learn: Specialty Technical Topics (Updated)
- Presentation and Transcript: Monkeypox Test Development and Validation Webinar - September 14, 2022
September 16, 2022
- Revised Emergency Use Authorization
- ASCA-Accredited Testing Laboratories (Updated)
- Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
September 15, 2022
- Re-issued Emergency Use Athorizations
- Class I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
- Meeting Notice: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
September 14, 2022
- Re-issued Emergency Use Authorizations
- Presentation and Transcript: Monkeypox Test Development and Validation Webinar - September 14, 2022
September 16, 2022
- Revised Emergency Use Authorization
- ASCA-Accredited Testing Laboratories (Updated)
- Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
September 15, 2022
- Re-issued Emergency Use Athorizations
- Class I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
- Meeting Notice: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
September 14, 2022
- Re-issued Emergency Use Authorizations
September 7, 2022
- New Emergency Use Authorization
- Monkeypox and Medical Devices
- Monkeypox Emergency Use Authorizations for Medical Devices
- Policy for Monkeypox Tests to Address the Public Health Emergency - Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff
- Summary Minutes: July 12-13, 2022 Patient Engagement Advisory Committee Meeting
September 6, 2022
- Revised Emergency Use Authorization
- Updated Emergency Use Authorization
- Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
- Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers
- Personal Protective Equipment EUAs (Updated)
- Mammography Facility Adverse Event and Action Report – September 6, 2022: Memorial MRI & Diagnostic, LLC
- Mammography Facility Adverse Event and Action Report – September 6, 2022: Ste. Genevieve County Memorial Hospital
September 2, 2022
September 1, 2022
- At-Home OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for OHC COVID-19 Antigen Self Test and CareStart COVID-19 Antigen Home Test)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210052 added)
- MQSA National Statistics (Updated)
August 31, 2022
- Class I Recall: Integra Recalls CereLink ICP Monitor for Risk of Incorrect Intracranial Pressure Readings
- MedSun Newsletter, September 2022 (PDF - 4MB)
August 30, 2022
- Revised Emergency Use Authorizations
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc. )
- CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
- Genabio COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.)
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- BioCode CoV-2 Flu Plus Assay (Applied BioCode, Inc.)
- MicroGEM Sal6830 SARS-CoV-2 Saliva Test (MicroGEM U.S., Inc.)
- Revoked Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Transcript for: July 12-13, 2022 Patient Engagement Advisory Committee Meeting
- Transcript for: July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting