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Getinge, Cook Medical Reach iCast Distribution Agreement

Getinge and Cook Medical have announced an exclusive sales and distribution agreement for the iCast covered stent system.

Endorail Earns FDA 510(k) clearance: Next-generation magnetic balloon technology optimizes colonoscopy procedural outcomes

Endostart, a pioneering medical device company specializing in gastrointestinal endoscopy solutions, HAS announces a major breakthrough with the FDA 510(k) clearance of its flagship product, Endorail. This achievement represents a significant step forward in advancing...

Survey: Nurse Shortage a Leading Threat to Industry

In honor of Certified Nurses Day, health tech company Carta Healthcare®, whose mission is to harness the value of clinical data, today released the results of a survey about the pain points that health care professionals are currently experiencing. The survey also...

Modular Lab Furniture Systems Meet Needs

UniLine Furniture offerings from HEMCO Corp. include base cabinets, wall cabinets, countertops, sinks, fixtures, base tables, mobile work stations, specialty storage cabinets and peg boards.

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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