Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA Moving on Pre-Cert Test Plan Despite Questions About Authority,” by David Roza. (Read the full version – subscription required.)

Following is an excerpt:

Despite lingering questions surrounding FDA’s authority to implement its software precertification program, the agency is moving forward with a pre-cert test program in which it hopes to test out its pre-cert model with a range of software companies. As the agency issued a call on Wednesday (May 22) for volunteers, one device industry lawyer questioned how useful participating in the 2019 test plan would be for companies, since they will not be awarded with precertification status at the end of the test. And, the lawyer added, it’s not even certain whether the pre-cert program will actually come to fruition. …

According to Brad Thompson, a member of the firm Epstein Becker Green, FDA likely doesn’t plan on offering the pre-cert designation to companies because of questions regarding the agency’s authority to do so.

FDA wrote in January that it would conduct the test pilot under its de novo pathway, saying the test would inform the agency whether it should seek other regulatory authorities.

However, experts disagreed over the legal sturdiness of that decision. Lawmakers have also questioned FDA’s authority to implement the pre-cert program and asked for more details from the agency, especially with regards to how it will hold firms to standards of safety and efficacy once they have been precertified.

Though FDA’s authority for pre-cert could eventually be further expanded, Thompson said one thing that is certain about the pre-cert test is the burden on companies that participate in it.

“If a company is planning to pursue a 510(k), then in order to participate in this program, all of a sudden they have to go through a full body cavity search for the excellence appraisal, including visits from FDA, as well as agree to all sorts of additional burdens such as collecting and providing real-world postmarket performance data,” Thompson said.

On top of those requirements, the company will still have to pursue the usual 510(k) process for getting its submission cleared by FDA, since the company will not be pre-certified at the end of the test, he added.

“All this leads me to wonder why a company would want to do this,” Thompson said.

He added: “I imagine that some companies will want to get in on the ground floor of the program, gaining experience early on. But obviously that only makes sense if you believe this program will ever come to fruition. Given the extraordinarily slow pace of and little progress in developing the program over the last couple of years, and the fact that they will need legislative authority, the future the program is quite uncertain.”

Although Thompson questions the whole process, he does acknowledge that the test plan does have stringent requirements that could help companies improve. In fact, he argued that FDA deliberately designed its excellence appraisal process and criteria to be aspirational, as by setting high standards, perhaps those companies can strive to be better.

“FDA believes that if most companies came in and pursued the excellence appraisal, most would currently fail, regardless of size or any other factor,” Thompson said. “They want companies to aspire to better pursue quality.”

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