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Must-Do Guidance Development: What's On Tap From Cures, MDUFA IV

US FDA's device center is facing new mandates and commitments to develop guidelines for industry. The guidance-development stipulations in the 21st Century Cures Act and the recent MDUFA IV user-fee agreement are detailed below.

The enactment this month of the 21st Century Cures Act on top of the draft MDUFA IV user-fee agreement inked between US FDA and industry this summer add a range of mandates and commitments for FDA's device center. Not least among those are guidance documents.

Guidance documents are intended to provide the bread-and-butter of what device companies need to know to get products to the US market and maintain compliance. The device center, on Dec. 22, issued its annual two-tier priority list for in-process guidance documents it hopes to finalize and new draft guidelines it hopes to rollout in FY 2017, which ends Sept. 30, 2017

More from United States

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

More from North America

‘Pathologists Are Hungry For AI-Enabled Digital Pathology’

 
• By Natasha Barrow

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.