US FDA and Device AI/ML

The US FDA has announced steps toward a new regulatory framework to promote the

development of medical devices that use advanced artificial intelligence / machine

learning algorithms - AI algorithms that can learn from and act on data. They have

already authorized some devices having AI capabilities. Their AI Good Machine

Learning Practice lists 10 “guiding principles” for ML/AI¹ to apply FDA’s current

authorities in new ways to keep up with the rapid pace of innovation and still ensure

device safety and performance.

The Agency is looking beyond elemental “locked” algorithm AI devices – devices that

don’t continually adapt or learn - to “true” AI - machine learning algorithms that

continually evolve, often called “adaptive” or “continuously learning” algorithms, that

learn through real-world use. The FDA is exploring a framework to allow modifications

to algorithms to be made from real-world learning and adaptation, while still ensuring

safety and effectiveness of the software required for premarket review. They include the

algorithm’s performance, the added concerns for AI / ML software verification and

validation, the manufacturer’s plan for modifications, and the ability of the manufacturer

to manage and control risks of the modifications, including the software’s

"predetermined change control plan".

¹ https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-

learning-practice-medical-device-development-guiding-principles

-- jel@jelincoln.com 

 Major FDA Changes – The Final Rule on LDTs (Lab Developed Tests):  Many companies who sell home test kits for STDs, drug abuse tests and similar OTC, e.g., on Amazon, CVS, Walgreens, etc., have relied heavily on the FDA’s tacit neglect under FDA’s “selective enforcement” of LDTs and their definition and legal requirements.  This now has changed radically with the issuance of the FDA’s Final Rule in the Federal Register (US law) on LDTs, on July 5, 2023¹.

 In their Final Rule, the FDA has brought LDT’s back to their original intent, i.e., a limited category of tests, manufactured / assembled by CLIA (Clinical Laboratory Improvement Amendments of 1988) labs, for which no viable alternative in IVT’s / other medical devices exist and for which “targeted selective enforcement” would be employed. All other “LDT” devices will be treated by the FDA as medical devices / IVDs. There will be a 5-stage 4-year phase-out² to full compliance. The phase-out dates start with the publication date of May 6, 2024. This Final Rule will pose major problems for current suppliers of so-called LDTs to clinicians, Amazon, CVS, Walgrens, etc.

 All LTV’s are medical devices, and now will be regulated as such, per the Final Rule, including company (commercial manufacturer / lab) registration, device listings, premarket review (510(k), PMA, IDE, De Novo) where applicable (Class II and III), adherence to the CGMPs for devices (21 CFR 820 / ISO 13485), FDA inspections, US FDA MDR reporting  (Medical Device Reporting), Labeling requirements, et al.  

 ¹Final Rule, LDTs:  https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests

 ²Phase-out Schedule:  https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/phaseout-policy-and-enforcement-discretion-policies-laboratory-developed-tests-faqs

-- jel@jelincoln.com