CDRHNew - News and Updates
January 23, 2020
January 23, 2020
January 22, 2020
January 21, 2020
- Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions - Guidance for Industry and FDA Staff
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170022 and DEN170073 added)
January 16, 2020
- Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine - March 5, 2020
- Press Release: Statement on quality issues with certain Cardinal Health surgical gowns and packs
- Federal Register: Requests for Nominations: Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
January 15, 2020
January 13, 2020
- Consumer Information on: LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc - P180038
- New CDRH Learn Modules: Production and Process Controls Part 2, Importing Medical Devices Into the United States, and Electronic Product Certification and Quality Testing Programs
- Federal Register: Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
January 10, 2020
- Essure Permanent Birth Control
- Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters--Premarket Notification (510(k)) Submissions
January 3, 2020
January 2, 2020
December 30, 2019
December 27, 2019
- Federal Register: Exemptions from Premarket Notification for Class I and Class II Devices
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notification
December 26, 2019
- Consumer Information: FoundationOne®CDx - P170019/S006
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180067 added)
December 23, 2019
December 20, 2019
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff
- Class I Recall: LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error
- Consumer Information: CentriMag Circulatory Support System - P170038
- Consumer Information: Tula® System - P190016
December 19, 2019
- Consumer Information: LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047
- Mammography Facility Adverse Event and Action Report - December 19, 2019: Radiology Disc of Encino
- Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy
- Transcripts posted for November 13-14, 2019 Immunology Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Neurological Devices: Reclassification of Cranial Electrotherapy Stimulator Devices Intended to Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended to Treat Depression
December 17, 2019
- Class I Recall: Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling
- Updated: How to Determine if Your Product is a Medical Device
- Class I Recall: GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall
December 16, 2019
- Class I Recall: Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall
- Consumer Information: LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab - P190011
December 13, 2019
- Press Release: FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system
- Press Release: FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190034 added)
- Consumer Information: Axonics Sacral Neuromodulation (SNM) System for Urinary Control – P180046
- Federal Register: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to Be Required in Electronic Format
December 12, 2019
- New Medical Device Development Tool - IMAnalytics with MRIxViP1.5T/3.0T And BCLib
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180056 added)
December 11, 2019
December 10, 2019
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180014 and DEN180058 added)
- Transcripts posted for November 6-7, 2019 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting
December 9, 2019
- Consumer Information: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear – P180035
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190016 added)
December 6, 2019
- Magnetic Resonance (MR) Coil - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff
- Framework for the Safety and Performance Based Pathway
- Federal Register: Magnetic Resonance Coil - Performance Criteria for Safety and Performance Based Pathway
December 4, 2019
- New Module on CDRH Learn: 513(g) Requests for Information
- Federal Register: National Mammography Quality Assurance Advisory Committee; Voting Members
- Federal Register: Public Advisory Panels of the Medical Devices Advisory Committee
December 2, 2019
- December 2, 2019 UPDATE: Latest Interim post-approval study (PAS) Results Are Available for the Abiomed Impella RP System
- Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging
- Federal Register: Submission of Information on Pediatric Uses of Medical Devices