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Food and Drug Administration (FDA) › Certification Requirements

Holland & Knight LLP

Not All Gruyere Comes From Gruyère: A Primer in Geographic Certification Marks

Holland & Knight LLP on

In a decision characterized by the National Milk Producers Federation as a "momentous victory for American consumers, farmers and food manufacturers" and a "huge victory for worldwide producers" of gruyere cheese, the U.S....more

Holland & Knight LLP

GSA and the VA Update COVID-19 Vaccination Requirements, Timelines and Testing Rules

Holland & Knight LLP on

Over the past few weeks, landlords leasing space to the General Services Administration (GSA) have begun to receive notices of requirements that all personnel operating in GSA space certify as to whether or not they have been...more

Mintz - Health Care Viewpoints

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

Mintz - Health Care Viewpoints on

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more

Fox Rothschild LLP

COVID-19 and Clinical Laboratories: Licensing Requirements For Diagnostic Testing

Fox Rothschild LLP on

Clinical laboratories across the country have ramped up their diagnostic testing capabilities to meet the critical need for COVID-19 testing, which is essential to mitigating the spread of the virus. Many labs are responding...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

Dorsey & Whitney LLP

FDA Testing New Approaches for Review of Digital Health Device Applications

Dorsey & Whitney LLP on

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more

Hogan Lovells

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

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Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

Hogan Lovells

To certify or not to certify? FDA has answered the question

Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

McGuireWoods LLP

It Will Only Cost You an Audit: FDA Releases FSMA Third-Party Certification Rule

McGuireWoods LLP on

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications...more

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