July 28, 2023

• GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings
• Consumer Information: LiquiFix FIX8 and LiquiFix Precision Hernia Mesh Fixation Devices - P220024 (Advanced Medical Solutions, Limited)
• CDRH Petitions (Updated)

July 27, 2023

• Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance for Industry and Food and Drug Administration Staff
• Webinar - Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance - September 14, 2023
• Class I Recall:  Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent
• Federal Register: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
• Federal Register: Medical Devices--Voluntary Improvement Program
• Federal Register: Medical Device User Fee Rates for Fiscal Year 2024
• Federal Register: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations--Premarket Notification (510(k)) Submissions

July 26, 2023

• Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers (Updated)
• Registration and Listing of Medical Devices Relating to COVID-19 (Updated)
• Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
• Class I Recall: Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism
• Hydrogen Peroxide Solution (Updated)

July 25, 2023

• Revised Emergency Use Authorization
  • C-Sync COVID-19 Antigen Test (Biosynchronicity Corporation)
• Consumer Information: DETOUR Systems - P220021 (Endologix, LLC)
• Consumer Information: FoundationOne Liquid CDx (F1 Liquid CDx) - P190032/S010 (Foundation Medicine, Inc.)

July 24, 2023

• CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization
• Sterilization for Medical Devices (Updated)

July 21, 2023

• New Emergency Use Authorization
  • ALPHADx SARS-COV-2 RT-PCR Test (Alphadera Labs, LLC)
• Class I Recall: Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients (Updated)

July 20, 2023

• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• New Emergency Use Authorization
  • Swab-N-Go Home Test COVID-19 Ag (Immunostics Inc.)
• Revised Emergency Use Authorization
  • Alinity m MPXV (Abbott Molecular, Inc.)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)

July 19, 2023

• Consumer Information: Optilume BPH Catherter System - P220029 (Urotronic, Inc.)
• Revised Emergency Use Authorizations
  • Metrix COVID-19 Test (Aptitude Medical Systems Inc.)
  • Xpert Xpress CoV-2/Flu/RSV plus (Cepheid)
• Updated Emergency Use Authorization
  • LumiraDx SARS-CoV-2 RNA STAR (LumiraDx UK, LTD)
• Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel - Letter to Health Care Providers
• CDRH Learn (Updated)
  • Device Registration and Listing: An Introduction – Part 1
  • Device Registration and Listing: An Introduction – Part 2 
  • An Introduction to the Medical Device User Fee Program: MDUFA V

July 18, 2023

• Revoked Emergency Use Authorization
  • BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) (Becton, Dickinson and Company)
• Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy
• Consumer Information: Eversense E3 Continuous Glucose Monitoring (CGM) System - P160048/S021 (Senseonics, Incorporated)
• CDRH Learn (Updated)
  • Printable Slides for Content of Premarket Submissions for Device Software Functions, Final Guidance
• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
• At-Home OTC COVID-19 Diagnostic Tests
  • Expiration Dates Extended: MaximBio ClearDetect COVID-19 Antigen Home Test

July 17, 2023

• Class I Recall: Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction
• Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
• Medical Device Development Tools (MDDT) (Updated)
• Medical Device Development Tool (MDDT) Proposal Submission Content (Updated)
• Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication
• Clinical Laboratory Improvement Amendments (CLIA) (Updated)
  • CLIA Categorizations (Updated)
  • CLIA Waiver by Application (Updated)

July 14, 2023

• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
• Medical Device Shortages List (Updated)
• Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)

July 13, 2023

• Surgical Mesh Used for Hernia Repair (Updated)
  • Information for Patients (Updated)
  • FDA Activities (Updated)
  • Reporting Problems to the FDA (Updated)
• CDRH Petitions (Updated)
• U.S.-Japan Regulatory Collaboration (Updated)
• Class I Recalls:
  • NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates
  • Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop
• Consumer Information: Inspire Upper Airway Stimulation - P130008/S090 (Inspire Medical Systems, Inc.)
• Consumer Information: VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) - P130010 (MicroPort CRM)
• Federal Register: Charter Amendments, Establishments, Renewals and Terminations: National Mammography Quality Assurance Advisory Committee

July 12, 2023

• Breakthrough Devices Program (Updated)
• Consumer Information: TactiFlex Ablation Catheter, Sensor Enabled - P220013 (Abbott Medical)

July 11, 2023

• MedSun Newsletter - July 2023
• Class I Recall: Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
• UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health Care Providers
• Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease (Updated)

July 10, 2023

• Revised Emergency Use Authorization
  • LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDX UK LTD)
• Consumer Information:
  • SKINVIVE by JUVÉDERM – P110033/S059 (Allergan Aesthetics)
  • Restylane Eyelight – P040024/S135 (Galderma Laboratories, L.P.)
• Electronic Export Documents – Letter to Industry
• CDRH Petitions (Updated)

July 7, 2023

• Revised Emergency Use Authorization
  • UOL COVID-19 Test (Uh-Oh Labs, Inc.)

July 6, 2023

• Revised Emergency Use Authorization
  • LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay (LumiraDx)
• Updated Emergency Use Authorizations
  • MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
  • ePlex Respiratory Pathogen Panel 2 (GenMark Diagnostics, Inc.)
• Dermal Fillers (Soft Tissue Fillers) (Updated)
• Automated External Defibrillators (AEDs) (Updated)

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 
  • Discover Labs COVID-19 Assay (Discover Labs)
• Revised Emergency Use Authorization
  • Status COVID-19 Antigen Rapid Test for Home Use (Princeton BioMeditech Corp.)
• 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
  • Lucira CHECK-IT COVID-19 Test Kit (Pfizer Inc.)

June 30, 2023

• eMDR System Enhancements (Updated)

June 29, 2023

• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

June 28, 2023

• UPDATE: NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers

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

• Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage

June 23, 2023

• Revoked Emergency Use Authorization
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
• Collaborative Communities – Updated with AFDO/RAPS AI Global Healthcare Initiative Collaborative Community
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
  • Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar 

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
  • INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
  • INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International, Ltd.)
• Meeting Notice: August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee

June 20, 2023

• Revised Emergency Use Authorization
  • Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay (Texas Department of State Health Services, Laboratory Services Section)
• 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
  • Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
  • Lucira by Pfizer COVID-19 & Flu Test (Lucira Health, Inc.)
  • Lucira by Pfizer COVID-19 & Flu Home Test (Lucira Health, Inc.)
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems, Inc.)
• Updated Emergency Use Authorization
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
• Revoked Emergency Use Authorization
  • BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))

June 15, 2023

• Consumer Information: FoundationOne Liquid CDx (F1 Liguid CDx) - P190032/S005 (Foundation Medicine Inc.)
• Updated Emergency Use Authorization
  • Xpert Ebola Assay (Cepheid)

June 13, 2023

• Reissued Emergency Use Authorization
  • ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.)
  • OSOM COVID-19 Antigen Home Test (SEKISUI Diagnostics, LLC.)
  • OSOM COVID-19 Antigen Rapid Test (SEKISUI Diagnostics, LLC.)
• 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

• Class I Recall: BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use

June 9, 2023

• New Emergency Use Authorization
  • In-Dx SARS-CoV-2 RT-LAMP Assay (Michigan State University laboratories, Department of Medicine Olin Student Health Center)
• 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
  • SARS-CoV-2 Acutis Multiplex Assay (Acutis Diagnostics)
• Medical Device Shortages List (Updated)
• Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)

June 6, 2023

• Revised Emergency Use Authorization
  • BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (Biofire Diagnostics, LLC) 
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220041, DEN200063, DEN210045 and DEN210046 added)

June 5, 2023

• Revoked Emergency Use Authorizations
  • Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test 
  • Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test 
• Revised Emergency Use Authorizations
  • ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
  • Atellica IM SARS-CoV-2 Antigen (CoVAg) (Siemens Healthcare Diagnostics, Inc.)
• Updated Emergency Use Authorizations
  • BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B (Becton, Dickinson and Company (BD)
• 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
  • TaqPath COVID-19 Pooling Kit (Thermo Fisher Scientific Inc.)
• 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

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)

May 25, 2023

• New Emergency Use Authorization
  • Bio-Self COVID-19 Antigen Home Test (BioTeke USA, LLC)
• Reissued Emergency Use Authorizations
  • SPERA COVID-19 Ag Test (Xtrava Health)
  • Quest Diagnostics Mpox Virus Qualitative Real-Time PCR (2-well) (Quest Diagnostics Nichols Institute)
• Revised Emergency Use Authorization
  • ID NOW COVID-19 2.0 (Abbott Diagnostics Scarborough, Inc.)
  • QIAreach SARS-CoV-2 Antigen (QIAGEN GmbH)
• 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

• Class I Recall: Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support

May 23, 2023

• Consumer Information: xT CDx - P210011 (Tempus Labs, Inc.)
• Revised Emergency Use Authorization
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular System)

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
  • DTPM COVID-19 RT-PCR Test - (DTPM, Inc.)   
• Revised Emergency Use Authorization
  • Status COVID-19/Flu A&B (Princeton BioMeditech Corp.) 
  • BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B (Becton, Dickinson and Company (BD)
• Updated Emergency Use Authorizations
  • Nano-Check COVID-19 Antigen At-Home Test (Nano-Ditech Corporation)
• 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
  • Nano-Check COVID-19 Antigen At-Home Test (Nano-Ditech Corporation)
• Reissued Emergency Use Authorization
  • Pilot COVID-19 At-Home Test (SD Biosensor, Inc.)
• 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
  • Clip COVID Rapid Antigen Test (Luminostics, Inc.)
• Reissued Emergency Use Authorization
  • iHealth COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
  • Metrix COIVD-19 Test (Aptitude Medical Systems Inc.)
• Revised Emergency Use Authorization
  • Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
• MDUFA Reports
  • May 10, 2023 MDUFA V Performance Report
  • May 10, 2023 MDUFA IV Performance Report

May 9, 2023

• Revised Emergency Use Authorizations
  • Atellica IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
  • ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
• 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
  • SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay (Drexel University College of Medicine)
  • Global Direct RT-PCR Test (Access Medical Laboratories, Inc.)
• Revised Emergency Use Authorizations
  • Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC)
• Updated Emergency Use Authorizations
  • InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
• 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
  • Princeton BioMeditech Corp Status COVID-19 Antigen Rapid Test for Home Use
• Revised Emergency Use Authorization
  • DxLab COVID-19 Test (DxLab Inc.)
• Cybersecurity (Updated)
• MQSA National Statistics (Updated)