CDRHNew - News and Updates
June 30, 2022
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Mammography Facilities with Revoked MQSA Certificate (Capitol Radiology, LLC 06-30-22)
- Mammography Facility Adverse Event and Action Report - June 30, 2022: Capitol Radiology, LLC doing business as Laurel Radiology Services
- Mammography Facility Adverse Event and Action Report - June 30, 2022: Medical University of South Carolina Hollings Cancer Center - Mobile Health Unit
- Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
June 29, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Medical Device Single Audit Program (MDSAP) (Updated)
- Federal Register: Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers
June 28, 2022
- Class I Recall: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down
- Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication
- CDRH Petitions (Updated)
June 27, 2022
- Revised Emergency Use Authorizations
- Transcript and Presentation added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 15, 2022
June 24, 2022
- Reissued Emergency Use Authorization
- Consumer Information on: FoundationOne CDx - P170019/S014
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Federal Register: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
June 23, 2022
- Reissued Emergency Use Authorizations
- Class I Recall: Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use
- Class I Recall: Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - 06/29/2022 (Updated)
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (fecha de vencimiento)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190037 and DEN190055 added)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: 510(k) Third-Party Review Program
- Federal Register: Dear Healthcare Provider Letters: Improving Communication of Important Safety Information
- Federal Register: Establishment Registration and Device Listing for Manufacturers and Importers of Devices
June 21, 2022
- Pruebas de diagnóstico de COVID-19 en el hogar: Preguntas frecuentes
- Class I Recall: Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow to Patients
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
June 17, 2022
- Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Draft Guidance for Industry and Food and Drug Administration Staff
- Laparoscopic Power Morcellators (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
June 16, 2022
- Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - 04/19/2022 (Updated)
- May 2022 PMA Approval List
June 15, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff
- CDRH Petitions (Updated)
- Federal Register: Administrative Procedures for Clinical Laboratory Improvement Amendments
- Federal Register: Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
June 14, 2022
- In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Updated)
- In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Celltrion Diatrust Update)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220006 added)
- UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers (Updated)
- FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Water-Based Heater-Cooler Devices (Updated)
- What is a Heater-Cooler Device? (Updated)
- Information for Patients (Updated)
- Recommendations for the Use of Water-Based Heater Cooler Devices (Updated)
June 13, 2022
- Prinatable Slides added - Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200062 added)
June 10, 2022
- New Emergency Use Authroziations
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Updated)
- Consumer Information on: GORE TAG Thoracic Branch Endoprosthesis – P210032
- Patient and Consumer Stakeholder Discussions on MDUFA V Reauthorization (September 2021 - March 2022 added)
June 9, 2022
- Reissued Emergency Use Authorizations
- Class I Recall: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA
June 8, 2022
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Class I Recall: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
June 7, 2022
- FAQs on Testing for SARS-CoV-2 (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200035 added)
- Sterilization for Medical Devices (Updated)
- Transcript and Presentation added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 1, 2022
- #186, MedSun Newsletter, June 2022
- Accreditation Bodies: How to Participate in the ASCA Pilot (Updated)
- Testing Laboratories: How to Participate in the ASCA Pilot (Updated)
- How to Study and Market Your Device (Information about Consensus Standards)
- Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
- Federal Register: Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
- Federal Register: Safety and Effectiveness Summaries for Premarket Approval Applications
June 6, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Voluntary eSTAR Program (Updated)
- Federal Register: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices: Questions and Answers; Withdrawal
- Federal Register: Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation
June 3, 2022
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Consumer Information on: ENROUTE Transcarotid Stent System – P140026/S016
- Class I Recall: Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms
- Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Electromagnetic Compatibility (EMC) (Updated)
- Federal Register: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices: Questions and Answers; Withdrawal
June 2, 2022
- UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
- Class I Recall: Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
- Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
- Cybersecurity (Updated)
- 2nd Quarter FY 2022 MDUFA IV Performance Report
June 1, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Reissued and Revised Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- MQSA National Statistics (Updated)
May 31, 2022
- Consumer Information on: AccelStim Bone Growth Stimulator – P210035
- Federal Register: Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals
May 27, 2022
- Meeting Notice: July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
- Class I Recall: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery