Publications

Hogan Lovells Publications

Clarifying digital health and software regulation: FDA releases three new guidance documents

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and...

Hogan Lovells Publications

FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of...

Hogan Lovells Publications

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device,...

Hogan Lovells Publications

Working together: FDA releases final guidance on interoperability

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for...

Hogan Lovells Publications

FDA’s software Pre-Cert program: More details revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert)...

Hogan Lovells Publications

FDA unveils software pre-certification pilot program to foster digital health innovation

Following promises in June for a new regulatory paradigm to address regulation of medical software, FDA released a Digital Health Innovation Action Plan on July 27, 2017, including a pilot...

Hogan Lovells Publications

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office...

Hogan Lovells Publications

New FDA Reporting Tool Encourages Whistleblowers


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