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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...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

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’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 Clarifies "Intended Use" Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in Establishing the Totality of the Evidence

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (FDA) amended the intended...

Hogan Lovells Publications

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and...

Hogan Lovells Publications

U.S. Senate passes 21st Century Cures Act, clearing numerous device-related provisions for the president’s signature

The U.S. Senate has just passed the 21st Century Cures Act, in line with the House of Representatives’ passage of the bill last week. This represents a culmination of efforts, dating...

Hogan Lovells Publications

New FDA Reporting Tool Encourages Whistleblowers


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