When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process for getting these devices to market. In January, FDA issued its new Software Precertification (Pre-Cert) Pilot Pro­gram working model 1.0, along with a test plan and regulatory framework. These documents explain how FDA reimagined its way of regulating digital health devices by looking at information across the total product life cycle.

According to FDA, “This proposed approach aims to look first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for traditional medical devices.” FDA notes that because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, it wants the regulatory framework to be equally responsive when issues arise to help ensure that consumers continue to have access to safe and effective products.

In 2019, the pilot program is entering its test phase. During this test phase, FDA says it will assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a software device prior to its introduction to the market, as compared to the traditional paradigm.

“While the FDA’s goal with the Pre-Cert program is to regulate digital health technologies in a way that fosters innovation, the model is based in protecting patient safety,” the agency says.

The newly released document in­cludes release notes detailing changes made from the previous version of the model and describes how the proposed key program components intersect. The test plan outlines how FDA intends to iterate and confirm that the framework proposed in the working model provides a reasonable assurance of safety and effectiveness for software products. The “Pre-Cert Regulatory Framework for Conducting the Pilot Program” lays out how FDA will implement the pilot program within its current authorities.

“As the FDA leverages insights from testing of Pre-Cert 1.0, we envision offering the voluntary program to manufacturers of software in a medical device (SiMD), and other software that could be considered accessories to hardware medical devices,” notes the agency.

FDA will host a webinar February 7, 2019, to help clarify software developers’ questions about the program, including the working model. FDA encourages software developers to review the model, test plan, and regulatory framework before the session. The agency is seeking public input on the Pre-Cert working model through the public docket by March 8, 2019.

Sherrie Trigg

Editor and Director of Medical Content

To learn more about the precertification program and to download version 1.0 of the working model, go here.