CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
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)
April 27, 2023
- Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
- FAQs on Viral Transport Media During COVID-19 (Updated)
- 24 Hour Summary for April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
April 26, 2023
- New Emergency Use Authorizations
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210055, DEN220033, DEN220059 and DEN220085 added)
- Consumer Information: NeuRx Diaphragm Pacing System - P200018 (Synapse Biomedical, Inc.)
April 25, 2023
April 24, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorizations
- Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication (Updated)
- Federal Register: Authorization of Emergency Use of a Medical Device During COVID-19
April 21, 2023
- Class I Recall: Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds
- Consumer Information on: Inspire Upper Airway Stimulation - P130008/S089
- CDRH Learn (Updated)
- Presentation and Transcript - Webinar on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
April 19, 2023
- Revised Emergency Use Authorization
- Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment
- GUDID Data Trends (Updated)
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Revocation
April 18, 2023
- Revised Emergency Use Authorization
- Revoked Emergency Use Authorizations
- Detect Covid-19 Test (Detect, Inc.)
- OmniPATH COVID-19 Total Antibody ELISA Test (Thermo Fisher Scientific)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
April 17, 2023
- New Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Jobs at the Center for Devices and Radiological Health (CDRH) (Updated)
- CDRH Learn (Updated)
- Printable Slides: Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
April 14, 2023
- Revised Emergancy Use Authorization
- Federal Register: In Vitro Diagnostic Device in Response to an Outbreak of Mpox
April 13, 2023
- Revised Emergency Use Authorizations
- Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)
- UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- Federal Register: Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters--Premarket Notification (510(k)) Submissions
April 12, 2023
- Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire (Updated)
- Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
April 11, 2023
- Revised Emergency Use Authorization
- CDRH Announces Radiation Sterilization Master File Pilot Program
- Sterilization for Medical Devices (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program
April 10, 2023
April 7, 2023
- Consumer Information: iCAST Covered Stent System – P120003 (Atrium Medical Corporation)
- Class I Recall: Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
April 6, 2023
- Patient Preference Information (PPI) in Medical Device Decision Making (Updated)
- Class I Recall: Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire
- Scientific Fellowships at CDRH (Updated)
April 4, 2023
- Updated Emergency Use Authorizations
- Recognized Consensus Standards (IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION added)
- Automated External Defibrillators (AEDs) (added Avive Pad Cartridge - Avive Solutions, Inc.)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200011 added)
- Virtual Town Hall - Test Development and Validation During the COVID-19 Public Health Emergency - April 26, 2023
April 3, 2023
March 31, 2023
- Updated Emergency Use Authorizations
- Revised Emergency Use Authorizations
- LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
- Sampinute COVID-19 Antigen MIA (Celltrion USA, Inc.)
- Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.)
- Sofia 2 Flu + SARS Antigen FIA (Quidel Corporation)
- Sienna-Clarity COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- QuickVue At-Home COVID-19 Test (Quidel Corporation)
- Consumer Information: RelayPro Thoracic Stent-Graft System - P200045/S002 (Bolton Medical, Inc.)
- Consumer Information: CALCIVIS Imaging System - P170029 (CALCIVIS Limited)
- Consumer Information: VENTANA PD-L1 (SP263) Assay - P160046/S013 (Ventana Medical Systems, Inc.)
- Problems Reported with Essure (Updated)
- FDA Activities Related to Essure (Updated)
- Expiration Dates Extended for Three OTC COVID-19 At-Home Tests (OHC COVID-19 Antigen Self Test, Flowflex COVID-19 Antigen Home Test, InteliSwab COVID-19 Rapid Test)
- Class I Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss
- Federal Register: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions
March 30, 2023
- Revised Emergency Use Authorizations
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff
- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices
- Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance - April 13, 2023
- Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication
- Medical Device Development Tool (MDDT)
- New tool: Computational Tool Comprising Visible Human Project Based Anatomical Female CAD Model and Ansys HFSS/Mechanical FEM Software for Temperature Rise Prediction near an Orthopedic Femoral Nail Implant during a 1.5 T MRI Scan
March 29, 2023
- Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff
- Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
- Cybersecurity (Updated)
- Voluntary eSTAR Program (Updated)
- Federal Register: Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
- Federal Register: Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
- Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension: M6-C Artificial Cervical Disc
- Federal Register: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems under the Federal Food, Drug, and Cosmetic Act
March 28, 2023
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Revised Emergency Use Authorizations
- Federal Register: Premarket Approval of Medical Devices
- Federal Register: Testing Communications by the Center for Devices and Radiological Health
- Federal Register: Orthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions
March 27, 2023
- CLIA Waived - Sysmex XW-100 CW210002 (Updated)
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- CDRH Learn (Updated)
- Presentation, Transcript, and Printable Slides: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19 - March 22, 2023
- Federal Register: Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway
- Federal Register: General Considerations for Animal Studies Intended to Evaluate Medical Devices
March 24, 2023
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
- FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
- FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19 (Updated)
- Importing Medical Devices Relating to COVID-19 (Updated)
- Diagnostic Data Program
- Federal Register: Transition Plan for Medical Devices Issued Emergency Use Authorizations Related to Coronavirus Disease 2019
- Federal Register: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency
March 23, 2023
- Reissued Emergency Use Authorization
- Updated Emergency Use Authorizaiton
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication
March 22, 2023
- CorDx COVID-19 Ag Test (CorDX, Inc.)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- Status COVID-19/Flu A&B (Princeton BioMeditech Corp.)
- BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))
- ePlex Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)
- TaqPath COVID-19 Fast PCR Combo Kit 2.0 (Life Technologies Corporation)
- TaqPath COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)
March 21, 2023
- New Emergency Use Authorization
March 20, 2023
- Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
- Pediatric X-ray Imaging (Updated)
- Microwave Ovens (Updated)
- Federal Register: Medical Devices: Technical Amendments
March 17, 2023
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- March 22 Will Be the Last Recurring Virtual Town Hall in the Series on Test Development and Validation During Public Health Emergencies – Mpox and COVID-19
- Class I Recall: Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure
March 16, 2023
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Ejection Fraction Tool (ELEFT) (Anumana, Inc.)
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
March 15, 2023
March 14, 2023
- Revoked Emergency Use Authorizations
- Idylla Ebola Virus Triage Test (Biocartis NV)
- FilmArray NGDS BT-E Assay (BioFire Defense, LLC)
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
March 13, 2023
- New Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Public Workshop - Appropriate Use of Consensus Standards - 12/07/2022 (Transcript Added)
- Joint Public Workshops - Medical Devices for Opioid Use - 11/07-08/2022 (Transcript Added)
March 10, 2023
- Consumer Information on: Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System - P160043/S058 (Medtronic Vascular)
- Revised Emergency Use Authorization
- Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Custom Device Reporting
March 9, 2023
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Frequently Asked Questions About MQSA (Updated)
- Federal Register: Mammography Quality Standards Act
- Federal Register: Emergency Use Authorization: Certain Medical Devices during COVID-19
- Federal Register: In Vitro Diagnostic Device in Response to an Outbreak of Mpox
March 8, 2023
- Consumer Information on: StableVisc and TotalVisc Ophthalmic Viscosurgical Device - P220009 (Bausch Health Companies, Inc.)
- Updated Emergency Use Authorization
- In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Updated)
- In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210033 and DEN220039 added)
- UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication
- CDRH Statement: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants
- Federal Register: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
March 7, 2023
- CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test
- Meeting Notice: April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
- CDRH's Experiential Learning Program (Updated)
- Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers
March 6, 2023
- Revised Emergency Use Authorizations
- Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- Sofia SARS Antigen FIA (Quidel Corporation)
- VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
- Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
- Reissued Emergency Use Authorizations
- Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
- Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
March 3, 2023
- Updated Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Speedy Swab Rapid COVID-19 Ag Self-Test (Watmind USA) - extended expiration dates
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (Actualizado)
- COVID-19 y prueba casera de la gripe de Lucira (Lucira Health, Inc.)
- Autodiagnóstico COVI-Go SARS-CoV-2 Ag (Mologic, Inc.)
- Prueba casera de GenBody para el COVID-19 Ag (GenBody Inc.)
- Prueba auto-diagnóstico rápido del antígeno CLINITEST para el COVID-19 (Siemens Healthineers)
March 2, 2023
- MDUFA Reports
- MQSA National Statistics (Updated)
March 1, 2023
- Updated Emergency Use Authorization
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers