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Freedom of Information Act › Medical Devices

The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal... more +
The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal agency records and enforce that right in a court of law. However, not all agency records can be requested; there are nine exempt categories of information. In addition to the federal law, many states have passed their own freedom of information acts. These acts are often similar but not always identical to the federal version.  less -
Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

Epstein Becker & Green on

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Wilson Sonsini Goodrich & Rosati

FDA Launches Website for Allegations Against Medical Device Manufacturers

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more

Troutman Pepper

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

Troutman Pepper on

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - November 2013

Akin Gump Strauss Hauer & Feld LLP on

INTRODUCTION - Welcome to the November 2013 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. On the anticorruption front, a Swiss tech company’s former exec is charged in the US...more

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