Publications

Hogan Lovells Publications

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the ...

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

FDA finalizes 3D printing guidance

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive...

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

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 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

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).

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