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# Lawmakers Seek Answers on FDA Digital Health Pathway
- URL: https://www.fdaweb.com/lawmakers-seek-answers-on-fda-digital-health-pathway/
- Published: 2018-10-10T12:00:00.000Z
- Updated: 2026-09-15T00:37:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142558

Sens. **Elizabeth Warren** (D-MA), **Patty Murray** (D-WA), and **Tina Smith** (D-MI) have raised concerns about CDRH’s regulation of digital health devices and the Center’s “Pre-Certification for Software Pilot Program,” which is part its broader effort to modernize the regulatory approach to digital health devices. In a [10/10 letter](https://www.warren.senate.gov/imo/media/doc/2018.10.10%20Letter%20to%20FDA%20on%20regulation%20of%20sofware%20as%20medical%20device.pdf?ref=fdaweb.com) to the agency, the senators ask for answers to a list of questions to get a “better understanding of how the agency plans to use this precertification pilot to inform its efforts to regulate digital health products and to improve its post-market surveillance system for medical devices.”

The lawmakers write that any changes to FDA's regulatory framework for overseeing software-based medical products should be “done in compliance with the current statutory framework and do not compromise public safety. The agency should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable. Instead, the Pre-Cert Pilot focuses heavily on the potential of standards for design, validation, and maintenance of software and the ability to capture post-market data to reduce premarket review time or eliminate the need for premarket review all together.”

  
The letter also notes concern with the precertification pilot’s development related to whether there should be a “phased market authorization” of a “software as a medical device (SaMD), in which some elements are reviewed premarket and other elements are gathered through real world evidence to support full market authorization.” It questions how such a conditional approval pathway is acceptable based on previous agency positions that rejected this approach for human medical products, including SaMDs. The letter requests answers by 11/9.