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FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

FDA Releases Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices

The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” in accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).

The executive summary of the report states: “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time. Although we do not believe that additional, formal regulatory action is warranted, based on the available information and findings, we intend to pursue the following actions:

  1. Promote the Adoption of Quality Management Principles;
  2. Clarify the Difference Between Servicing and Remanufacturing;
  3. Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
  4. Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing.”

Download a PDF of the report here.

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