CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.govon June 18, 2019. To view listings for other dates, see CDRH New - News and Updates.

Consumer Information on: Hintermann Series H3™ Total Ankle Replacement System - P160036 Evaluation of Automatic Class III Designation (De Novo) Summaries added

June 19, 2019

• Federal Register: Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices

June 18, 2019

• Consumer Information on: Hintermann Series H3™ Total Ankle Replacement System - P160036
• Evaluation of Automatic Class III Designation (De Novo) Summaries added

June 17, 2019

• Consumer Information on: TransMedics OCS Lung System - P160013/S002
• Meeting Materials posted for June 19-20, 2019 Circulatory System Devices Panel

June 12, 2019

• Mouse Embryo Assay for Assisted Reproduction Technology Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Federal Register: Mouse Embryo Assay for Assisted Reproduction Technology Devices

June 11, 2019

• Consumer Information on: The therascreen PIK3CA RGQ PCR Kit - P190001 and P190004

June 10, 2019

• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records

June 7, 2019

• Webcast Links posted for June 19-20, 2019 Circulatory System Devices Panel
• Press Release: FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

June 6, 2019

• Consumer Information on: Eversense Continuous Glucose Monitoring System - P160048/S006

June 5, 2019

• Meeting Materials posted for June 19-20, 2019 Circulatory System Devices Panel

June 4, 2019

• 24 Hour Summary posted for May 30-31, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

June 3, 2019

• May 2019 PMA Approval List

May 31, 2019

• Consumer Information: Neuroform Atlas® Stent System - P180031

May 30, 2019

• Class I Recall: Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath
• Mammography Facility Adverse Event and Action Report - May 30, 2019: East Palestine Family Medical Clinic Inc.

May 28, 2019

• Federal Register: Notice: Review and Update of Device Establishment Inspection Processes and Standards; Extension of Comment Period
• Meeting materials posted for May 30-31, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

May 24, 2019

• Class I Recall: lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock
• Class I Recall: Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the Device to Stop Working or Catch Fire
• Federal Register: Amendment of Notice: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
• Federal Register: Notice: Determination of Regulatory Review Period for Purposes of Patent Extension: EDWARDS INTUITY ELITE AORTIC VALVE
• AMENDMENT OF NOTICE: May 30-31, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

May 23, 2019

• UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures
• Class I Recall: Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of Inaccurate Results
• Consumer Information on: LOTUS Edge™ Valve System - P180029
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180069 and DEN180032 added)
• Historical Information about Device Emergency Use Authorizations
• Consumer Information: NovoTTF™-100L System - H180002
• Press Release: FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results
• Press Release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
• Press Release: FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

May 22, 2019

• Digital Health Software Precertification (Pre-Cert) Program: Participate in 2019 Test Plan
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180059 added)

May 21, 2019

• UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers
• Warning Letter to Zeller Power Products, LLC
• Consumer Information: VICI VENOUS STENT® System - P180013

May 20, 2019

• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals
• Press Release: FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

May 17, 2019

• FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication
• Patient-Reported Outcomes (PROs) in Medical Device Decision Making
• Federal Register: Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction