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FDA Issues Final Rule On Electronic Registration And Listing Of Devices

This article was originally published in The Gray Sheet

Executive Summary

The rule formally implements requirements established by the FDA Amendments Act of 2007.

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Draft Guidance Aims to Demystify 510(k) Ownership

The proposed guidance explains how FDA tracks 510(k) clearance ownerships, and the agency’s actions and requirements during disputed 510(k) listings.

CDRH Extends Device Establishment Registration Deadline

The device center has extended the annual medical device registration period by one month to Jan. 31, as companies and FDA adopt new registration and registration fee requirements established in the FDA Safety and Innovation Act and recent regulatory revisions.

Regulatory News In Brief

Stryker resolves another warning letter: The firm has resolved the second of four warning letters received since 2007 related to quality issues, Stryker reported March 23. Following a 2009 re-inspection and further corrective actions, FDA determined the company had sufficiently addressed a November 2007 warning letter for quality system problems at its reconstructive implant manufacturing facility in Mahwah, N.J. No further formal corrective actions are required, Stryker said. Last fall, FDA lifted another of the warning letters, this one for quality system and compliance violations at the orthopedic device maker's biotech division (1"The Gray Sheet" Oct. 26, 2009). Stryker initiated a three-year, roughly $200 million compliance program overhaul in 2008 (2'The Gray Sheet" Feb. 2, 2009)

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