FDA Archives - In Compliance Magazine

FDA Offers Online Tracker for Premarket Submissions

The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system to help companies track the progress of the agency’s review of their 510(k) submissions. The FDA’s Premarket Submission’... Read More...

FDA Releases Discussion Paper on Medical Device Cybersecurity Challenges

The U.S. Food and Drug Administration (FDA) has released a discussion paper on specific cybersecurity practices related to the servicing of medical devices. The discussion paper, “Strengthening Cybersecurity... Read More...

FDA Extends Comment Period on Remanufacturing of Medical Devices Guidance

The U.S. Food and Drug Administration (FDA) has extended the public comment period on its recently issued draft guidance on the remanufacturing and servicing of medical devices. According to a Notice published... Read More...

FDA Releases Guidance on UDI Systems for Medical Devices

The U.S. Food and Drug Administration (FDA) has published a Final Guidance on the form and content of unique device identifier (UDI) labeling and information required for medical devices. The FDA’s UDI requi... Read More...

FDA Issues Guidance on Remanufacturing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the agency’s view of what constitutes a “remanufactured” medical device and to help clarify regulatory requirements applicable... Read More...

FDA Seeks Budget Increase, Especially for Medical Device Review

The U.S. Food and Drug Administration (FDA) is seeking an increase of over $550 million in its total proposed budget for fiscal year (FY) 2022, reflecting in part a significant increase in its budget for oversi... Read More...

FDA Issues Guidance on Medical Device Safety in MRI Facilities

The U.S. Food and Drug Administration (FDA) has issued its final guidance on assessing the safety of medical devices used in facilities using magnetic resonance imaging (MRI) technologies. Published in late ... Read More...

FDA Releases 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process. ... Read More...

FDA Warns of Potential Effects of Magnets in Cell Phones and Smartwatches

The U.S. Food and Drug Administration (FDA) is advising consumers with embedded pacemakers and other implanted medical devices to take precautions when using consumer electronics with integrated magnets. In ... Read More...

FDA Reverses HHS Action to Exempt Certain Medical Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has withdrawn a January proposal by the U.S. Department of Health and Human Services (HHS) to permanently exempt 91 separate medical device types from the FDA’s 510(k... Read More...