Health Law Advisor

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions.  Congress broadly directed federal agencies to begin relying on standards in 1996, through the National Technology Transfer and Advancement Act, but the informal practice dates back to the 1970s.  Congress specifically directed FDA to begin using standards for medical device submissions through the Food and Drug Administration Modernization Act of 1997 (FDAMA). 

Being a curious person, I wanted to see what FDA has done with that authority by looking at the CDRH database for Recognized Consensus Standards: Medical Devices.  My main takeaway is that CDRH is not yet investing enough time and energy in recognizing standards that support digital health and AI.

Findings

I downloaded the data set on September 20, 2024, and looked when standards were recognized by FDA and to which therapeutic or functional areas they related.

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...

At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health Innovation Action Plan, FDA acknowledges that digital health technologies are critically important in advancing health care, and that traditional FDA pathways to market are not well suited for all of these technologies. Over the last few years, FDA has taken a deregulatory approach with respect to low risk digital health products and has issued guidance regarding its enforcement discretion approach to wellness products, medical device ...

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:

1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...