medical devices Archives - Effective Medicine

FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication

Date Issued: March 9, 2017 Audiences: Organ and tissue procurement organizations Organ and tissue transplantation centers Health Care Providers who conduct organ and tissue transplant procedures Health Care Providers who care for organ and tissue transplant recipients Operating Room Managers, Directors and Staff Risk Managers Patients considering organ or tissue transplantation Organ and tissue recipients…

FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication

Date issued: March 8, 2017 Audiences: Health care providers who manage the care of patients with autonomic dysfunction, including neurologists, interventionalists (radiologists, vascular surgeons, and neurosurgeons), and clinical researchers People considering treatment options for autonomic dysfunction, including but not limited to Parkinson’s disease, multiple sclerosis (MS), fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral…

Class I Medical Device Recall: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140033, DEN150035, DEN150055 and DEN160019 added)

1st Quarter FY 2017 MDUFA III Performance Report

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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150007 and DEN160032 added)

Presentations posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

Presentation and Transcript added to Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance

Neurovascular Thrombus Retrieval Catheters and Guide Catheters Used During Neurological Interventional Procedures: Differences in FDA Review and Intended Use

March 1, 2017 To promote safe and effective use of medical devices, the FDA’s Center for Devices and Radiological Health (CDRH) is clarifying the differences between neurovascular thrombus retrieval catheters and neurovascular guide catheters (e.g., intermediate catheter, distal access catheter). These devices are both cleared by FDA through the 510(k) premarket notification program. However, FDA…

The Annual MQSA Inspection: What Facilities Can Do To Help

The annual inspection under the Mammography Quality Standards Act (MQSA) is the time when an MQSA certified inspector assesses a facility’s compliance with MQSA quality standards. To reduce the amount of time away from the facility’s job of patient care, the scope of the standard inspection questions is designed to check areas that FDA believes…