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Regulating Software As A Medical Device Will Take Paradigm Shift, Former FDA Chief Counsel Says

 
• By Hannah Daniel

Sidley Austin partner and former FDA Chief Counsel Jeff Senger told Medtech Insight that the FDA’s software pre-certification program will need to clear manufacturers, as well as software itself.

• Source: Shutterstock

Evidence is mounting that keeping up with software used as medical devices (SaMD) will require assessing manufacturers as well as their products.

Last month, the US Food and Drug Administration published a report on the software pre-certification pilot that it had launched...

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More from Regulation

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

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.

More from Policy & Regulation

FDA’s AI Tool Won’t Make Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 
• By Brian Bossetta

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics