FitBit, Verily Make Inroads at FDA as it Weighs Software Rules

Health tech giants like Apple Inc. and Samsung Electronics Co. with an eye towards the future of smart medical devices are making inroads with federal officials exploring ways to regulate computer coding.

While volunteers in the Food and Drug Administration’s pre-certification pilot program won’t necessarily see their products hit the market faster, the experience could give them the inside track as the agency develops new approval methods for software-based medical devices.

Initial pilot participants said advancing digital health innovation is motivation enough, especially since the market for “smart” medical devices is large and expected to grow.

“This program aims to ...