Publications

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...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

What device companies need to know ahead of an advisory panel meeting

Preparing for advisory panel meetings
For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or...

Hogan Lovells Publications

New FDA final guidance on medical device panel meetings provides certain changes to timelines and procedures

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or,...

Hogan Lovells Publications

Clinical Evaluation of Medical Software: FDA Proposes International Guidance

On October 14, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document addressing clinical evaluation for standalone software. The draft guidance,...

Hogan Lovells Publications

Highly Anticipated FDA Draft Guidance Documents on 510(k) Device Modifications Add New Considerations to the Decision-Making Process for Companies

On August 8, 2016, FDA issued two highly anticipated draft guidance documents, entitled Deciding When to Submit a 510(k) for a Change to an Existing Device1 (general guidance) and Deciding ...

Hogan Lovells Publications

FDA Draft Guidance Reaffirms Utility of Real-World Evidence in Medical Device Regulatory Decision-Making

As part of a series of efforts1 by the U.S. Food and Drug Administration (FDA) to "think outside the box" when it comes to the evidence required to support regulatory decision-making, on...

Hogan Lovells Publications

When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices

This past year, FDA's Center for Devices and Radiological Health (CDRH) has dealt with several widely publicized public health issues related to medical devices.

Hogan Lovells Publications

New Draft Guidance Outlines FDA’s Key Considerations for Adaptive Designs in Clinical Studies

On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the...

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