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Freedom of Information Act › Medical Devices › Food and Drug Administration (FDA)

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 -
Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

Epstein Becker & Green

Unpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA

Epstein Becker & Green on

You may be familiar with the data that FDA publicly shares on devices designated as having breakthrough status, and devices ultimately approved after receiving that status....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 Locke

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

Troutman Pepper Locke 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

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