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Innovatus Imaging Launches TEE Probe Maintenance Program

Trans-Esophageal Echocardiology, or TEE Probes, used to create images of the heart via the esophagus, are among the most costly ultrasound devices imaging departments nationwide purchase in order to properly diagnose cardiac conditions. Each of these highly...

Clarius to Unveil Miniaturized Wireless Smartphone Ultrasound Scanners

Clarius Mobile Health is poised to deliver on its promise to make high-definition ultrasound more affordable and easier to use for every clinician. During its virtual Innovation Spotlight event on Monday, January 17, 2022, the company’s ultrasound pioneers will take...

AHRA Approves ICE Education

ICE 2022 is approved for 32 ARRT Category A CE credits by AHRA.

MUSC team demonstrates MRI scan in ambulance

Doctors at MUSC Health’s Comprehensive Stroke Center constantly work with their community hospital colleagues on initiatives to cut down the steps that need to happen between the time a stroke patient is wheeled through the ambulance bay until treatment can begin.

FDA Issues New Draft Guidance on Remanufacturing of Medical Devices and Discussion Paper on Cybersecurity and Servicing

Many medical devices are reusable and need maintenance and repair. Servicing of devices is critical to their safe and effective use. The U.S. Food and Drug Administration (FDA) has issued two documents as part of its ongoing efforts to help distinguish between remanufacturing and servicing. To clarify the activities that are likely “remanufacturing” of a device, the FDA issued the draft guidance: Remanufacturing of Medical Devices.

Read the Guidance »

Facts about the draft guidance

This guidance:

  • Helps clarify whether activities performed on devices are likely remanufacturing.
  • Is intended to describe the FDA’s current position on remanufacturing, and to clarify, not change, the regulatory requirements applicable to remanufacturers. It is not intended to adopt significant policy changes.

Discussion paper on cybersecurity and servicing

The FDA is also committed to strong cybersecurity practices related to the servicing of medical devices and is releasing a discussion paper, Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities, to outline cybersecurity issues that are unique to the servicing of medical devices.

Read the Paper »

Upcoming webinar on this guidance

On July 27, the FDA will host a webinar for stakeholders interested in learning more about the guidance and discussion paper.

Submit Comments

This draft guidance will be open for public comments for 60 days at https://www.regulations.gov under Docket Number FDA-2018-N-3741.

The discussion paper will be open for public comments for 60 days at https://www.regulations.gov under Docket Number FDA-2021-N-0561.

Questions?

If you have questions about this draft guidance or the discussion paper, contact the Division of Industry and Consumer Education.

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