FDA starts updating approach to SaMD

The FDA is considering changes to the way it regulates pathways for software used as a medical device (SaMD), according to law firm, Dentons.

The firm’s life sciences team reported on a public meeting held by the FDA titled "Fostering Digital Health Innovation: Developing the Software Precertification Program.”

The FDA currently classifies SaMD through the International Medical Device Regulators Forum (IMDRF) which includes four categories based on whether the SaMD is intended to treat, diagnose, drive and inform clinical management.

According to Dentons, the FDA is now working on a process of developing a more streamlined way to conduct premarket reviews and clearance as SaMD products. Dentons state that the new process is intended to be “better calibrated to the development, maintenance and lifespan of software products and services.”

Last year, the FDA launched its Pre-Cert programme , designed to help the agency determine if companies can submit less information than currently required before marketing a new digital health product. Nine companies are currently working with the FDA as part of the Pre-Cert programme, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool and Verily.

The FDA’s public meeting included workshops at which stakeholders were invited to participate to identify potential issues in the Pre-Cert programme.  

At the meeting, Dentons noted that the FDA indicated it would be willing to reconsider how it approaches processes for regulating device safety and effectiveness.

More so, Dentons highlights a range of issues identified during the workshop including if the Pre-Cert programme would use a traditional 510(K) or pre-market approval (PMA) process for SaMD devices; whether the programme will change the standards or length of pre-market review; how SaMD products will be cleared for market without clinical data which is currently required for premarket reviews and how the new regulatory pathway will apply to “software in a medical device (SiMD).

The FDA is also calling on stakeholders to offer “additional comments on evaluating and measuring a culture of quality and organizational excellence for the precertification element of FDA’s software precertification program by March 1, 2018.”