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

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

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

Highly Anticipated FDA Draft Guidance Documents on 510(k) Device Modifications Add New Considerations to the Decision-Making Process for Companies

On August 8, 2016, FDA issued two highly anticipated draft guidance documents, entitled Deciding When to Submit a 510(k) for a Change to an Existing Device1 (general guidance) and Deciding ...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 Issues New Guidance on Human Factors Testing for Medical Devices

On February 3, 2016, the Food and Drug Administration (FDA or the agency) released three guidance documents on human factors and usability engineering for medical devices. Applying Human...

Hogan Lovells Publications

Congress Suspends Medical Device Tax for Two Years

The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years of effort by industry to abolish the tax, ...

Hogan Lovells Publications

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

On November 17, 2015, leaders from both the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) testified before the U.S. House of Representatives...

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