Artificial Intelligence

Artificial Intelligence Medical DevicesDecember 19, 2024

Data Bias in AI/ML-Enabled MedTech Takes Center Stage in Forthcoming ISO TS 24971-2 Risk Management Doc

By Shawn M. Schmitt Communications Specialist, Enzyme Data bias in medical devices that are enabled with artificial intelligence (AI) and machine learning (ML) will play a front-and-center role in an upcoming Technical Specification (TS) document from the International Organization for Standardization (ISO). ISO TS 24971-2 will serve as a companion guide to ISO TR 24971:2020,...

Artificial Intelligence Digital Health Medical Devices RegulationOctober 31, 2024

FDA Drives ‘Stake In Ground’ With Glossary For AI, Digital Health Terms

By Shawn M. Schmitt Communications Specialist, Enzyme The US Food and Drug Administration (FDA) has taken a critical step toward ensuring that makers of medical devices are all on the same page when it comes to defining terms related to artificial intelligence (AI) and digital health, says an ex-agency official. Posted online in late September,...

Artificial Intelligence Medical Devices RegulationOctober 17, 2024

MedTech Makers Can Get Devices to US Market Faster, Hasten Innovation By Drafting PCCP Change Plans, Industry Experts Say

By Shawn M. Schmitt Communications Specialist, Enzyme A Predetermined Change Control Plan (PCCP) submitted to and approved by the US Food and Drug Administration (FDA) as part of the medical device review process can give some manufacturers a leg up by shaving months off of the time it can take for a product to come...

Artificial Intelligence Medical Devices SaMDOctober 15, 2024

Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech

By Shawn M. Schmitt Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster – and believes it’s a win-win for manufacturers and...

Artificial Intelligence Clinical Decision Support SaMD SiMDJune 15, 2023

What Caption Health’s FDA Approval Reveals About Successful PCCPs

The FDA’s draft guidance for predetermined change control plans (PCCPs) is months away from conversion into a final guidance, but that hasn’t stopped software developers from creating products with a PCCP component for the U.S. market. The FDA approved the de novo application by Caption Health on Feb. 24, 2023, for a machine learning (ML) product that processes ultrasound images to calculate left ventricular ejection fraction (LVEF).

Artificial Intelligence Digital Health PharmaJune 6, 2023

FDA Releases Discussion Paper for AI in Drug Development

This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.

Artificial Intelligence SaMDApril 12, 2023

FDA (Finally) Publishes Change Control Draft Guidance for Artificial Intelligence

Several features of this draft suggest companies will have to do a significant amount of work in the premarket phase for development of a predetermined change control protocol (PCCP), making the development process potentially lengthier and more expensive.

Artificial Intelligence Digital Health PharmaApril 5, 2023

FDA Takes Next Step Toward Digital Health in Drug Development

The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.

Artificial Intelligence Manufacturing PharmaMarch 21, 2023

FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing

The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.

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