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Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says

 
• By Sue Darcey

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Capitol Building, Washington, US, mirrored reflection

Diagnostics regulatory reform is on the agenda of the US House Energy and Commerce Committee this year, Rep. Diana DeGette, D-Colo., told Medtech Insight following a Jan. 16 Alliance for Health Policy briefing in Washington, DC. DeGette is a senior member of the committee and the new chair of the E&C Oversight and Investigations Subcommittee.

DeGette (pictured, right) suggested that the ‘Verifying Accurate Leading-edge IVCT Development Act’ (VALID Act), a proposed diagnostics reform bill developed...

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MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.