Next Steps For NEST: Planning Board Lays Out Launch Strategy For Evaluation System

A public-private National Evaluation System for health Technology (NEST) is gathering momentum following a recent funding agreement in the draft Medical Device User Fee Act IV deal. A planning board tasked with developing a NEST coordinating center has outlined projects to get the system off the ground. Also: Listen to our podcast interview with Mark McClellan about the project.

The Duke-Margolis Center for Health Policy has released a third report outlining steps to make a public-private National Evaluation System for health Technology (NEST) a reality. The center, which houses the planning board tasked with developing a coordinating center for NEST, proposed demonstration projects that would be phased in two stages to show how best to share data and develop best practices.

US FDA is a major advocate for NEST, stating the program would improve surveillance of medical products on the market...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

US FDA Unveils Plans To Consolidate Support Services

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By 

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 

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.

More from North America

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.