A look at the FDA’s approach to medical device regulations

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The U.S. Food and Drug Administration (FDA) regulates the development, manufacturing, authorisation, distribution and sale of more than 190,000 different types of medical devices in more than 6,700 different product categories. The FDA’s definition of a medical device includes everything from gauze and bandages to COVID-19 tests to pacemakers and ventilators. 

Medical devices are categorised as Class I to III based on the potential risk posed to the public. Class I devices pose the least risk and include things like bandages and handheld surgical instruments. Class III devices pose the highest risk and include products such as pacemakers and breast implants. Regulatory control increases as risk increases, which means Class III devices have more regulatory requirements than products categorised as Class I or Class II.

Medical devices can also be grouped by classification panel based on their medical specialty. More than 1,700 generic device types—groups of devices without varying characteristics in terms of safety and efficacy and requiring comparable regulatory controls—have been classified by the FDA and divided into 16 medical specialties including cardiovascular and orthopaedic.

However, as medical technology changes and care is delivered in new ways, the FDA needs to adapt. One example relates to the software used in medical settings. In 2019, the FDA published draft guidance for Clinical Decision Support (CDS) Software that left a lot of room for interpretation. In September 2022, the agency issued its final guidance, which offered some clarification. Ultimately, it stated that to be excluded from the definition of a device, a software must meet all four criteria that describe the types of CDS software that are not regulated as devices under the definitions in section 520(o)(1)(E) of the Federal Food, Drug & Cosmetics Act (FD&C Act). 

This third criterion is the subject of one of the new guidance's most contentious interpretations. The FD&C states that as long as the software "provides condition-, disease-, and/or patient specific recommendations" to a healthcare professional (HCP) in order to "enhance, inform, and/or influence a health care decision but is not intended to replace or direct the HCP's judgment," CDS software isn't considered to be a device. However, CDS would be regulated as a medical device if it is used in "time-critical decision-making" or in situations "when a software function provides a specific preventive, diagnostic or treatment output or directive.”

This clarification opens the door for more CDS to be regulated as a medical device, which will be a concern both for developers and for manufacturers who may need to adjust product timelines to include more oversight from the FDA. Since FDA guidance is not by itself a legally binding rule, the industry will undoubtedly be watching how the agency implements the changes.

Another way that the FDA is working to stay current is by looking at its own internal structure. To provide more focused executive leadership and better serve stakeholders, the agency divided the Office of In Vitro Diagnostics and Radiological Health into two separate offices: the Office of Health Technology 7 (OHT7), Office of In Vitro Diagnostics, and the Office of Health Technology 8 (OHT8), Office of Radiological Health.

These new offices will be responsible for activities in the total product lifecycle of devices under their purview, which include premarket review programs such as 510(k), premarket approval, De Novo classifications and others, the full range of compliance and quality programs such as establishment inspection reports, regulatory audit reports, recalls, enforcement actions and surveillance programs, such as medical device reports and safety signals.

While the activities for each office will be similar, there is a big difference between technology used in radiological health and devices considered in vitro diagnostics (IVDs), which the FDA defines as "tests conducted on samples obtained from the human body, such as blood or tissue." This covers every type of test, from COVID-19 and home pregnancy tests to lab blood testing.

The creation of the two different offices acknowledges these differences and ways that approvals and testing may vary between the two types of devices.

The COVID-19 pandemic further put the FDA to test when the desperate need for at-home tests arose. Some companies tried to take advantage of this demand and rushed to get their products on the market quickly, sometimes without FDA approval. However, there was also confusion about processes during this time, so some companies may have thought they had done everything right and still found themselves in violation.

In April of 2022, the FDA launched a tool to help consumers know they were using real FDA-approved tests. The Counterfeit At-Home OTC COVID-19 Diagnostic Tests provided information for identifying unauthorized or counterfeit tests and lists all COVID-19 tests the agency had identified as counterfeit. This quick response provides a clear example of how the FDA handles emerging issues.

The COVID-19 pandemic put a lot of pressure on the FDA to keep the public safe under extremely challenging conditions. Similarly, medical device companies and their suppliers were pushed to the limit in preventing shortages of life-saving products. As new technologies and applications for medical devices are introduced, manufacturers must develop good working relationships with the FDA to help make marketing authorisations go as smoothly as possible. For its part, the FDA should keep looking for ways to evolve with the new demands from consumers and the industry.