On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly 3 years since the pilot was kicked off. With big-name participants like Apple, Fitbit, and Samsung being among the nine pilot participants, an update to this first of its kind program from the agency has been highly anticipated...

1. 2020 Updates to FDA’s Pre-Cert Program
By: Madison Wheeler
On Monday, the FDA providedan update on its software precertificationprogramknown commonly
as the Pre-Cert Program. This update comes over a year since the first working model of the pilot
program was published by the agency, and nearly 3 years since the pilot was kicked off.1 With big-
name participants like Apple, Fitbit, and Samsung being among the nine pilot participants, an update
to this first of its kind program from the agency has been highly anticipated.
The pre-cert programisa continuousevaluationprogramaimed at developersof software asamedical
device (SaMD). Essentially, through the pre-cert program, the FDA will examine the developer rather
than the device. Companiesmust pass a certain criterionand “demonstrate a robust culture of quality
and organizational excellence” to be certified, which will in turn allow the developer to go through a
streamlined agency reviewof SaMD products; this is referredto as the FDA’s TotalProduct Lifecycle
(TPLC)approach.2 Back in 2019, the agency releasedits first test plan to determine if it’s evaluationof
developersthrough the pre-cert program coupled with the streamlined review processof their SaMD
productscanequate to more traditionalclearance pathways(like the 510k)intermsof achievingFDA’s
standard of safety and effectiveness.
This year’s update details what the agency’s next steps are in the continued mission to make this
program a reality. The update details what will be involvedwithassessing development firms, the first
step in the TPLC. This will be an organization-level analysis that looks first for that robust quality
culture mentioned earlier, and then for a wealth of demonstrated evidence. The basis for this
evaluationwillinclude lookingat product quality, clinical/cybersecurity responsibility, andaproactive
culture to name a few.3
The next step in the TPLC is to conduct a streamlined review of the SaMD itself. This year’s update
states that the agency is considering basing this step on the claims made for the product. This is big
news for developers because it means that pre-certified firms would be able to market lower-risk
devices with either an extremely simple agency review or no premarket review at all. Products that
would still warrant a reviewcan be expectedto be examined for product performance (including real-
worlddata), the clinicalassociationbetweenSaMD output and clinicalcondition, and safety measures.
Although this program is highly anticipated by the industry, it is still early in its development stage.
Firms should not expect to see this pre-cert program come to full reality for at least a few more years
until the agency thoroughly vets that it can protect public health. If you are developing an SaMD,
EMMA International has a team of quality and regulatory experts that can help get your product
through the FDA’s process. Give us a call at 248-987-4497 or email info@emmainternational.com to
see how we can help.
1 FDA(September 2020) Pre-CertPilotProgram: Milestones and Next Steps retrieved on 09/15/2020from: https://www.fda.gov/medical-
devices/digital-health-software-precertification-pre-cert-program/precertification-pre-cert-pilot-program-milestones-and-next-steps
2 FDA(September 2020) Digital Health Software Precertification Programretrieved on09/15/2020 from: https://www.fda.gov/medical-
devices/digital-health/digital-health-software-precertification-pre-cert-program
3 FDA(September 2020) Developing theSoftwarePrecertification Program, Summary ofLearnings andOngoing Activities retrieved on
09/15/2020 from: https://www.fda.gov/media/142107/download