Regulatory News In Brief

FDA issues documents on advisory committee financial conflicts and scientific integrity. More regulatory updates.

FDA will begin publicly disclosing the name of the company or institution associated with an advisory committee member’s financial conflict of interest, according to a final guidance released March 9. The document, “Public Availability Of Advisory Committee Members’ Financial Interest Information and Waivers,” includes minor revisions to the April 2010 draft to improve clarity, and replaces an August 2008 guidance, FDA says. (See Also see "FDA Works To Fill Panel Vacancies While Tightening Conflict Rules" - Medtech Insight, 26 April, 2010..) FDA is required to vet all potential advisory committee members for conflicts of interest and disclose on its website “the type, nature and magnitude of any disqualifying financial interest” when considering giving a waiver to a potential advisory committee member. FDA also will indicate the magnitude of a financial interest by dollar range, such as $0-$5,000, on its website.

FDA issued its scientific integrity policy in a staff manual guide that went into effect on Feb. 3....

More from Regulation

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By 

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

More from Policy & Regulation

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.