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Medical Devices › Regulatory Requirements › Product Labels

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

DLA Piper

EPA Expands Mandatory Federal Purchasing Program

DLA Piper on

The US Environmental Protection Agency (EPA) recently announced that it is expanding its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing Program (Recommendations Program) to include new...more

Arnall Golden Gregory LLP

FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products

Arnall Golden Gregory LLP on

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published in the Federal Register a proposed rule titled, “Regulations Regarding ‘Intended Uses.’”...more

Blake, Cassels & Graydon LLP

Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care

Blake, Cassels & Graydon LLP on

COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more

Hogan Lovells

FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

Hogan Lovells on

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as “consistent with" FDA-required labeling. FDA...more

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