CDRHNew - News and Updates
October 22, 2021
- 24 Hour Summary for October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
- Transcript and Summary Minutes for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
October 21, 2021
October 20, 2021
- Updated Emergency Use Authorizations
- Medical Device Reporting (MDR): How to Report Medical Device Problems (Updated)
- Presentation Slides added to Virtual Public Workshop - Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices - October 14, 2021
October 19, 2021
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff
- Hearing Aids (Updated)
- Other Hearing Devices and Products (Updated)
- Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
- Federal Register: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Availability
- Federal Register: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
October 18, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 20, 2021
- Studies Using Leftover, Deidentified Human Specimens Require IRB Review – Letter to Industry
- Materials for October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
October 14, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Class I Recall: Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results
- Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers (Updated)
- Video and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 6, 2021
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
October 13, 2021
- Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
- UDI Rule and Guidances, Training, Resources, and Dockets (Updated)
- GUDID Guidance (Updated)
- Unique Device Identification System (UDI System) (Updated)
- UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers
- FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices (Updated)
- What Is a Heater-Cooler Device? (Updated)
- Third Party Performance Report - FY21, Q4
- Federal Register: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
October 12, 2021
- New Emergency Use Authorization
- Updated Emergency Use Authorization
- Re-issued Emergency Use Authorization
- Quest Diagnostics Infectious Disease, Inc.
- 24 Hour Summary for October 6, 2021 Patient Engagement Advisory Committee Meeting
- Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication
October 8, 2021
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
- Video and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - September 22, 2021
- Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication
- Dermal Fillers (Soft Tissue Fillers) (Updated)
- Reclassification (Updated)
October 7, 2021
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations - Guidance for Industry and Food and Drug Administration Staff
- UPDATE: Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers
- Surgical Staplers and Staples (Updated)
- Federal Register: General and Plastic Surgery Devices: Reclassification of Certain Surgical Staplers
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Labeling Regulations
- Federal Register: Guidance: Surgical Staplers and Staples for Internal Use--Labeling Recommendations
- First Database of Tumor Mutations Recognized by the FDA as a Scientifically Valid Source for Test Developers
October 6, 2021
- Class I Recall: DeRoyal Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set
- In Vitro Diagnostics EUAs (Updated)
- Class I Recall: Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use
October 5, 2021
- New Emergency Use Authorization
- Updated
- Cybersecurity Awareness Month at the FDA
- Cybersecurity (Updated)
- Job Opportunities at OSEL (Updated)
- Class I Recall: Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing (Updated)
- Video added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 4, 2021
- Video added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 11, 2021
- Federal Register: Guidance Documents Related to Coronavirus Disease 2019
- Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
- Class I Recall: Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
October 4, 2021
- Consumer Information on:
- Virtual Public Meeting - Orthopedic Strategically Coordinated Registry Network Meeting - November 4, 2021
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
- De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff
- User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
- Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
- De Novo Classification Request (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190055 added)
- Federal Register: Medical Device De Novo Classification Process
- New Emergency Use Authorization
October 1, 2021
- MQSA National Statistics
- Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
September 30, 2021
- Device Registration and Listing (Updated)
- Video added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 18, 2021
- Video added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 25, 2021
- MDUFA IV Independent Assessment Report
September 29, 2021
- Essure Permanent Birth Control (Updated)
- FDA Activities Related to Essure (Updated)
- Problems Reported with Essure (Updated)
- Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication
- Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 18, 2021
- Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 25, 2021
September 28, 2021
- All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination (Updated)
- Electronic Submission Template for Medical Device 510(k) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- 510(k) Program Pilots (Updated)
- Federal Register: Electronic Submission Template for Medical Device 510(k) Submissions
- Revocation - Emergency Use Authorization
- Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)
- Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results (Updated)
- Materials posted for October 6, 2021 Patient Engagement Advisory Committee Meeting
- CDRH Petitions (Updated)
September 27, 2021
- New Emergency Use Authorization
- Re-issued - Emergency Use Authorization
- Updated - Emergency Use Authorizations
- Materials posted for October 6, 2021 Patient Engagement Advisory Committee Meeting
- Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers
- Good Clinical Practice (GCP) Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic (IVD) Device Premarket Submissions
September 24, 2021
- New Emergency Use Authorization - Viral Mutation Revision Letter
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
September 23, 2021
- New Emergency Use Authorization
- Updated Emergency Use Authorizations
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200080 added)
- Class I Recall: Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 6, 2021
- Federal Register: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
September 22, 2021
- Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
- Medical Device Material Safety Summaries: ECRI Reports
- FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices
- Class I Recall: Cordis Recalls Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge
September 21, 2021
- Re-Issued Emergency Use Authorization
- Consumer Information on: VENTANA MMR RxDx Panel - P210001
- Virtual Public Workshop - Orthopedic Device-Related Infections II Workshop - December 3, 2021
- Consumer Information on: RelayPro Thoracic Stent-Graft System - P200045