CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
July 5, 2023
- Updated Emergency Use Authorization
- OHC COVID-19 Antigen Self Test (Osang, LLC.)
- SPERA COVID-19 Ag Test (Xtrava Health)
- Revoked Emergency Use Authorization
- CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)
- MQSA National Statistics (Updated)
July 3, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests
- iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
- Status COVID-19 Antigen Rapid Test for Home Use (Princeton BioMeditech Corp.)
- Updated Emergency Use Authorization
June 30, 2023
- eMDR System Enhancements (Updated)
June 29, 2023
June 28, 2023
June 27, 2023
- Consumer Information: REFLECT Scoliosis Correction System - H210002 (Globus Medical, Inc.)
- Patient-Matched Guides to Orthopedic Implants - Draft Guidance for Industry and Food and Drug Administration Staff
June 26, 2023
June 23, 2023
- Revoked Emergency Use Authorization
- Collaborative Communities – Updated with AFDO/RAPS AI Global Healthcare Initiative Collaborative Community
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
June 22, 2023
- Ventilators and Ventilator Accessories EUAs: Ventilators Removed from Appendix B (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force (Updated)
June 21, 2023
- Revised Emergency Use Authorizations
- Meeting Notice: August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee
June 20, 2023
- Revised Emergency Use Authorization
- Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210038, DEN210040 and DEN220048 added)
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee
June 16, 2023
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorization
- Revoked Emergency Use Authorization
June 15, 2023
- Consumer Information: FoundationOne Liquid CDx (F1 Liguid CDx) - P190032/S005 (Foundation Medicine Inc.)
- Updated Emergency Use Authorization
June 13, 2023
- Reissued Emergency Use Authorization
- Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions - July 20, 2023
- Voluntary eSTAR Program (Updated)
- Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220078 added)
- Federal Register: Content of Premarket Submissions for Device Software Functions
June 12, 2023
June 9, 2023
- New Emergency Use Authorization
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220028 added)
- Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers
- Voluntary eSTAR Program (Updated)
- Federal Register: Adverse Event Program for Medical Devices (Medical Product Safety Network)
- Federal Register: Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
- Federal Register: Premarket Notification of Devices
June 8, 2023
- New Emergency Use Authorization
- Medical Device Shortages List (Updated)
- Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)
June 6, 2023
- Revised Emergency Use Authorization
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220041, DEN200063, DEN210045 and DEN210046 added)
June 5, 2023
- Revoked Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Class I Recall: Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
- Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies - Letter to Health Care Providers
June 2, 2023
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff
- UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)
- MQSA National Statistics (Updated)
June 1, 2023
- Revised Emergency Use Authorization
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies
- Jobs at the Center for Devices and Radiological Health (CDRH)
- Current Career Opportunities at CDRH
- Why Choose CDRH for Your Career?
May 31, 2023
- Hurricane Emergency Preparedness and Medical Devices: Recommendations for Health Care Providers, Device Manufacturers and Distributors
- Consumer Information: Sculptra - P030050/S039 (Q-Med AB)
May 30, 2023
May 25, 2023
- New Emergency Use Authorization
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorization
- Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Guidance for Industry and Food and Drug Administration Staff
- Laparoscopic Power Morcellators (Updated)
- Federal Register: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
May 24, 2023
May 23, 2023
May 22, 2023
- Consumer Information: ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total Quality Control (HBcT2 QC) - P210019/S002 (Siemens Healthcare Diagnostics Inc.)
- Class I Recall: ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery
May 18, 2023
- Reissued Emergency Use Authorization
- Revised Emergency Use Authorization
- Updated Emergency Use Authorizations
- Meeting Notice: September 6, 2023 Patient Engagement Advisory Committee
May 17, 2023
- Consumer Information: Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (serafilcon A) - P220007 (Alcon Laboratories, Inc.)
- Consumer Information: MiniMed 780G System - P160017/S091 (Medtronic MiniMed, Inc.)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Boson Rapid SARS-CoV-2 Antigen Test
May 16, 2023
- New Emergency Use Authorization
- Reissued Emergency Use Authorization
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220083 added)
May 12, 2023
- Coronavirus (COVID-19) and Medical Devices
- COVID-19 Emergency Use Authorizations for Medical Devices
- Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
- Contacts for Medical Devices Related to COVID-19
- Information for Filing Personal Protective Equipment and Medical Devices Relating to COVID-19
- Registration and Listing of Medical Devices Relating to COVID-19
- Medical Device Supply Chain and Shortages
- Medical Device Shortages List
- Supply and Shortages of Medical Devices: Frequently Asked Questions
- Notify the FDA About a Medical Device Supply Issue
May 10, 2023
- Revoked Emergency Use Authorization
- Reissued Emergency Use Authorization
- Revised Emergency Use Authorization
- MDUFA Reports
May 9, 2023
- Revised Emergency Use Authorizations
- Consumer Information: Lava Liquid Embolic System – P220020 (BlackSwan Vascular, Inc.)
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
May 8, 2023
- In Vitro Diagnostics Emergency Use Authorizations (EUAs) - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)
- MedSun Newsletter - May 2023
- Transcript: April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
- Consumer Information: Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management - P210037 (BIOTRONIK NRO, INC.)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210038 and DEN210040 added)
May 5, 2023
- Antimicrobial Resistance and Medical Devices
- CDRH Learn (Updated)
- Presentation, Transcript, and Printable Slides: Virtual Town Hall Series, Test Development and Validation During the COVID-19 Public Health Emergency, April 26, 2023
- MDSAP QMS Procedures and Forms (Updated)
- MDSAP QMS Documents (Updated)
May 4, 2023
- Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1
- Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading
- VICTRE: In Silico Breast Imaging Pipeline
- Endoscope Geometric Distortion- A Method for Quantitative Evaluation (Updated)
- Infrared Thermographs- Methods for Evaluating Laboratory Performance (Updated)
- Method for Estimating the Likelihood of Wireless Coexistence (Updated)
- Modified Dot-Blot Method to Evaluate Personal Protective Equipment (PPE) (Updated)
- Verification Test Problems for Cardiac Electrophysiology Modeling Software (Updated)
May 3, 2023
- OTC Hearing Aids: What You Should Know
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210032 and DEN220039 added)
May 1, 2023
- New Emergency Use Authorizations
- Revised Emergency Use Authorization
- Cybersecurity (Updated)
- MQSA National Statistics (Updated)