By Jeffrey H. Brochin, J.D.
Medical device classification regulations have been amended to reflect changes to the federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act), which excluded from the definition of a ‘device’ certain software functions.
The FDA has published a final rule in which it has updated eight classification regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act. The Cures Act amended, among other things, the FDA’s authority to regulate medical software, including certain clinical decision support software (Final rule, 86 FR 20278, April 19, 2021).
Enactment of Cures Act. On December 13, 2016, the Cures Act was enacted which amended the FDA’s authority to regulate medical software, including certain clinical decision support software. The provision of the Cures Act entitled ‘‘Clarifying Medical Software Regulation,’’ amended section 520 of the FD&C Act by adding subsection (o), which described specific software functions to be excluded from the definition of ‘device’ in the FD&C Act.
Exclusions from definition of device. Section 520(o)(1) of the FD&C Act excluded from the definition of ‘device software’ functions that are intended for, among other things:
- administrative support of a healthcare facility;
- maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
- serving as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as such records were created, stored, transferred, or reviewed by healthcare professionals or by individuals working under supervision of such professionals;
- transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a healthcare professional with respect to such data and results, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, or findings;
- displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);
- supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition; and,
- enabling such healthcare professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such healthcare professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.
Provision for adverse health consequences. The Cures Act also provides that a software function will not be excluded from the device definition under section 201(h) of the FD&C Act if the FDA makes a finding that the software function would be reasonably likely to have serious adverse health consequences and certain substantive and procedural criteria are met. Also, nothing in section 520(o)(1) should exclude regulated software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans.
FDA classification amendments. As a result of needing to amend the FD&C Act to conform to the Cures Act, the FDA has amended the classification regulations for eight devices as follows:
- calculator/data processing module for clinical use;
- continuous glucose monitor secondary display;
- automated indirect immunofluorescence microscope and software-assisted system;
- medical device data system;
- home uterine activity monitor;
- medical image storage device;
- medical image communications device; and
- picture archiving and communications system.
The FDA final rule became effective upon publication in the Federal Register on April 19, 2021.
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