If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start

International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

Behtany Hills and Bakul Patel
Life science attorney Bethany Hills and the FDA's Bakul Patel at the 2019 World Medical Innovation Forum in Boston • Source: Ferdous Al-Faruque

Regulators around the world are watching what the US FDA is doing to build a new pathway for software as a medical device (SaMD), according to Bakul Patel, associate director of digital health at the agency's Center for Devices and Radiological Health. He also says the recent discussion paper on artificial intelligence is not the be all and end all before the agency develops a draft guidance on the topic.

During a panel discussion at the 2019 World Medical Innovation Forum in Boston, Patel noted he and other international regulators have been working for the past five

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 Regulation

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

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

 

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.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

More from Policy & Regulation

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By 

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By 

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

 

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.