Verily Study Watch receives 510(k) clearance from FDA

The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems.  The idea is that the Verily watch would be worn similar (or as!) a consumer device but allow certain types of medical device functionality to be enabled or utilized.  This obviously has great implications and opportunities for general population health.

Traditionally an idea such as this would be considered unlikely to meet regulatory requirements for medical devices.  However with the 21st Century Cures Act in the US and the new FDA Digital Health Unit, we are seeing a new approach emerging for device clearance for products in this space.  The FDA Pre-Cert program promises to formalize this new approach that uses more of a “qualify the process, not necessarily the product”.  It remains to be seen how this will ultimately manifest and how it will ultimately affect the quality of these medical devices.

I certainly hope that companies in the digital space will embrace software quality assurance activities and employ solid software safety risk management methods.  IEC 80002-1 would be a great place to start.  Designing in safety risk controls is easy when the software engineer is aware of the need and purpose of the control early in the project, or early in the release cycle.  Adding safety handling infrastructure can be difficult to do later.  Also a quick tour through our software related recalls library should produce a healthy bit of caution to not be overconfident with software functionality – bugs that cause an app to restart are one thing, but bugs that inaccurately report physiologic measurements can be deadly.

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.