MITA Raises Questions With Pre-Cert Software Pilot

Regulatory NewsRegulatory News | 07 March 2019 |  By 

The Medical Imaging & Technology Alliance (MITA) this week raised questions about the value of participating in a new US Food and Drug Administration (FDA) Pre-Certification pilot for software as a medical device (SaMD) products.

While noting how an increasing number of SaMD products are coming to market to be used in the diagnosis and treatment of medical conditions, MITA Executive Director Patrick Hope says the alliance supports efficient FDA oversight to allow products to come to market more quickly.

“It is unclear, however, in what way and to what extent Pre-Cert will actually accomplish this,” he says, noting the costs associated with the program for participants, which include developing more rigorous post-market surveillance systems and sharing different kinds of information as well as larger amounts of information.

“Bearing these costs must be rewarded with clear expectations for reduced regulatory burden,” Hope adds. And though the Pre-Cert pilot says it will streamline certain regulatory processes, the actual regulatory efficiency “is difficult to determine and not quantified in any concrete manner,” he adds.

Another concern for MITA is how FDA will gauge the success of the Pre-Cert pilot.

“How, a few years into implementation, will the Agency determine if more and safer devices have been brought to market more efficiently? Similarly, how will the Agency assess the impact on public health of implementation of this program?” Hope questions.

Last October, three senators similarly raised questions about the pilot, noting the “statutory basis for FDA's deployment of this more agile, tailored framework is unclear.”

The letter followed a joint statement from FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren highlighting two de novo clearances the agency granted for new mobile medical apps for use on the Apple Watch. The world’s most valuable company is one of the nine participants selected last year to help provide routine feedback to the Pre-Cert program.

More recently, FDA issued a three-part update in January on the pilot, detailing how the agency intends to operationalize the pilot within its current authorities and test it in 2019 using its de novo regulatory review pathway.


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