FDA Policy/General

FDA Seeking Feedback on AI/ML-Based Software Regulation

An FDA discussion paper is seeking comments on a proposed framework for modifications to artificial intelligence- and machine learning-based software as a medical device that is based on the internationally harmonized International Medical Device Regulators Forum risk categorization principles, FDA’s benefit/risk framework, management principles in the agency’s software modification guidance, and the organization-based total product lifecycle approach as envisioned in the digital health software precertification program. The paper “describes an innovative approach that may require additional statutory authority to implement fully. The proposed framework is being issued for discussion purposes only and is not a draft guidance. This document is not intended to communicate FDA’s proposed (or final) regulatory expectations but is instead meant to seek early input from groups and individuals outside the agency prior to development of a draft guidance,” it says.

In the framework, FDA introduces a “predetermined change control plan” in premarket submissions that would include the types of anticipated modifications and the associated methodology being used to implement the changes in a controlled manner that manages risks to patients. In this approach, FDA says, the agency would expect a commitment from manufacturers on transparency and real-world performance, monitoring for artificial intelligence and machine learning-based software as a medical device, as well as periodic updates to FDA on what changes were implemented as part of the approved pre-specifications and the algorithm change protocol.

“The proposed regulatory framework could enable FDA and manufacturers to evaluate and monitor a software product from its premarket development to postmarket performance,” FDA says. “This potential framework allows for FDA’s regulatory oversight to embrace the iterative improvement power of artificial intelligence and machine learning-based software as a medical device, while assuring patient safety.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome