Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Regulatory Affairs Professionals Society (RAPS), in “CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design,” by Ana Mulero.

Following is an excerpt:

As the US Food and Drug Administration (FDA) seeks to establish a new regulatory paradigm for digital health products by year’s end, the feedback received from a range of stakeholders on the proposed approach has continued to raise more questions than answers.

Officials at the FDA’s Center for Devices and Radiological (CDRH) have stressed the need for input on the creation of the new program — the Software Precertification Pilot Program — aimed at providing a fast track to the US market for participating digital health developers. …

The last comment period closed in June, with 11 submissions posted on the working model version 0.2. These include GE Healthcare and the Clinical Decision Support Coalition (CDS), which expressed concerns over regulatory burden and FDA staffing challenges.

CDS general counsel Bradley Merrill Thompson also raised doubts about the benefits to companies with low-risk products.

“For those products that are ultra-low risk, the calculus is even more tilted toward staying out of the precert program,” Thompson wrote. “For those companies, the Pre-Cert program offers nothing, so the burdens of the program entirely outweigh the benefits.”

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.