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How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of medical device software will be exempt from regulation. Section 3060, Clarifying Medical Software Regulation, identifies five categories of medical software that will not be regulated as medical devices by the FDA due to their potential low level of risk to patients. The software categories that may be excluded from device regulation include: Administrative & Operational Software: that provides administrative support of a healthcare facility, such as that for appointment scheduling, health benefit eligibility and processing financial records. While this software is included in the provision, it was not considered a medical device to begin with. Wellness Apps: for maintaining or encouraging a healthy lifestyle that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. This is consistent with FDA’s General Wellness and Mobile Medical Applications guidance documents. Electronic Patient Record Software: provided that it is only intended to transfer, store, convert formats or display the equivalent of a medical chart. There are some caveats to this exception, however: Records must be created, stored, transferred or reviewed by healthcare professionals; Records must be part of health information technology certified under section 3001(c)(5) of the Public Health Service Act; and The software must not be intended to interpret or analyze patient data or images for the diagnosis, cure, mitigation, prevention, or...
Obama Signs the 21st Century Cures Act into Law

Obama Signs the 21st Century Cures Act into Law

Last night, President Obama signed the 21st Century Cures Act into law. Most of what people will be hearing from the media will be focused on the Act’s support of cancer research, mental health policies, brain research to tackle diseases like Alzheimer’s and the funding allocated for these initiatives. However, the 996-page bill also includes major changes that impact the way the FDA regulates drugs, devices and biologics. Those who have spoken out against the Cures Act have done so out of fear of a weakened system that would allow for less rigorous examination of products before they go to market. While there are sections of the act that appear to streamline submission and review processes, until the FDA develops the necessary guidances based on their interpretation of the requirements, the industry will not know what to expect. The best way to approach these pending changes is to become familiar with the areas that might impact your device. The following summarizes provisions relevant to medical device companies: Sec. 3001 Patient Experience Data Under the Cures Act, FDA would be required to include a statement regarding any patient experience data that was used at the time of a drug’s approval. The bill defines patient experience data as “data collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers).” While this section specifically refers to drugs, this may come into play for combination products, as well. This requirement, as well as section 3002, is one to watch to determine if it affects your product commercialization goals. Sec. 3033 Accelerated...