Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing

Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.

Several senators pressed FDA commissioner nominee Robert Califf about what could be done to improve postmarket device surveillance during his Nov. 17 confirmation hearing in the Senate Health, Education, Labor and Pensions Committee. And Califf, currently a deputy commissioner at FDA, emphasized the need for funding from Congress to expand the Sentinel surveillance system to track device safety.

HELP Committee ranking member Patty Murray, D-Wash., raised the issue during the hearing particularly in relation to contamination incidents with...

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 Legislation

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

More from Policy & Regulation

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By 

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.