FDA Validates Streamlined Review of SaMD Under PreCert Pilot
Posted 18 July 2019 | By
In a Thursday update on the US Food and Drug Administration’s (FDA) Precertification (PreCert) pilot program for software as a medical device (SaMD), the Center for Devices and Radiological Health (CDRH) said retrospective testing supported the streamlined review of SaMD.
CDRH’s PreCert team retrospectively tested previously reviewed submissions in May to see if the accelerated review pathway tailored to SaMD products provides the same level of reasonable assurance of safety and effectiveness as the traditional review pathways for medical devices. To support the retrospective testing, a mock excellence appraisal summary was developed based on visits to the sites of the nine companies participating in the pilot and submitted comments. The CDRH team then combined the reviews of previous submissions with the mock excellence appraisals.
Results from the retrospective testing of submissions, which were selected at random from different product areas, support the feasibility of the streamlined review process with the mock excellence appraisal, CDRH said. Moving forward, the framework will be used to support regulatory determinations.
CDRH Digital Health Director Bakul Patel said in an interview with Focus
that the team made the decision to focus solely on whether the two-pronged premarket process can be used to support SaMD determinations while safeguarding FDA’s gold standard of safety and effectiveness prior to testing other elements. With the outcome of the retrospective testing, Patel added that the team will now look to pilot the mechanism that defines whether a premarket review is necessary or whether there should be a streamlined review.
By piloting voluntary review pathway determination pre-submissions, the PreCert team aims to inform those in the prospective testing process early on about any data missing in submissions.
The first product submitted via the PreCert pilot program is Pear Therapeutics’ Somryst for the treatment of chronic insomnia and depression in adults. Patel said the PreCert team will apply to Pear’s new submission the structured format, review processes and work instructions recommended to support the shift from retrospective to prospective testing of submissions.
The precertification levels have drawn criticism in comments submitted to the versions of the working model. CDRH has sought input from more than just the nine pilot participants to shape the working model into its current version, which Patel said will remain as is. He added that CDRH will only open another comment period if there are significant changes.
PreCert ultimately seeks to help SaMD products reach the market and into the hands of patients and health care providers than current processes allow, with yet another element intended to support this objective being organizations’ commitment to real-world performance analytics.
Software Precertification Program 2019 Mid-Year Update