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Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases

 
• By Brian Bossetta and Hannah Daniel

The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.

Hands typing on laptop with five document icons floating above it.
• Source: Shutterstock

The US Food and Drug Administration issued four guidance documents on 29 September, the first a final guidance “Antimicrobial Susceptibility Test System Devices—Updating Breakpoints in Device Labeling,” which the agency said is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC) — or breakpoints — and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices.

Timely adoption of updated breakpoints in AST system devices is important, according to the FDA, because it helps to...

More from Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

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.