Publications

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

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...

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

FDA signals increasing focus on cybersecurity requirements

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical...

Hogan Lovells Publications

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain...

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 issues long-awaited final guidance on when a device modification requires a new 510(k)

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and ...

Hogan Lovells Publications

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

The rapid development of medical software products continues to create regulatory challenges for the Food and Drug Administration (FDA).

Hogan Lovells Publications

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of...

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