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Philips Launches AI-enabled MR Portfolio of Smart Diagnostic Systems

Royal Philips has announced new AI-enabled innovations in MR imaging launching at the Radiological Society of North America (RSNA) annual meeting. Philips’ new MR portfolio of intelligent integrated solutions is designed to speed up MR exams, streamline workflows,...

RSNA 2021 Expects Nearly 20,000 Attendees in Chicago

The Radiological Society of North America (RSNA) today announced that more than 19,000 attendees are registered to attend the Society’s 107th Scientific Assembly and Annual Meeting (RSNA 2021) at McCormick Place in Chicago (Nov. 28-Dec. 2), with another 4,000...

Hyland Healthcare to Demo Enterprise Imaging Solutions at RSNA

Hyland Healthcare will detail the company's robust enterprise imaging solutions at RSNA 2021. Hyland Healthcare continues to research and innovate in the space as to meet demands from its health care customers, as systems grow and data becomes more ubiquitous. As data...

Konica Minolta Healthcare Releases New Devices

Konica Minolta Healthcare Americas, Inc., announces the launch of the mKDR Xpress Mobile X-ray System and the AeroDR Carbon Flat Panel Detector, two solutions that are powerful alone yet extraordinary when used together. These new solutions reaffirm Konica Minolta’s...

FDA Draft Guidance on Medical Device Establishment Inspections

The FDA has issued a draft guidance regarding how it will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic medical device establishments.

The FDA updated processes and standards to address the new provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a), and to establish a standard timeframe for inspections. This draft guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance describes the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Interested parties may submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions about this document contact the ORA Office of Strategic Planning and Operational Policy (OSPOP) at ORAPolicyStaffs@fda.hhs.gov.

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