Publications

Hogan Lovells Publications

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

Hogan Lovells Publications

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...

Hogan Lovells Publications

FDA releases working model for Software Precertification Pilot Program

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its ...

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)...

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