Regulatory Working Group

Charter

Clarification and description of interoperable devices functions in a regulatory environment.

Scope includes both pre-market and post-market.
Scope includes international regulatory bodies:
- FDA
- Health Ministry of Japan
- EU member states
- Health Canada
- Therapeutic Goods Administration (TGA Australia)
- And others
Investigate official approaches to clarifying regulation of interoperable devices (Could be 513(g). Could be form 3429. Could be a white paper. Could be some other process yet to be determined.)

Educate and socialize the FDA and other regulatory bodies on Continua and interoperable devices.

Education and helping each alliance company. Which could include:

Testing and certification tools.
Shared resources.
Shared documentation and risk analysis.

Coordination with other Continua Working groups and providing input as appropriate.

Join

If you are interested in joining the Regulatory Working Group please click here and follow the join group link.

Chair

Scott Thiel

Regulatory Affairs Program Manager

Roche Diagnostics

Scott Thiel is a Regulatory Affairs Program Manager in Roche Diagnostics Global Diabetes Care Regulatory Group. He joined Roche Diagnostics in 1988 after receiving his BS in Biology and Chemistry from Ball State University in 1987 and working as a Medical Technologist. After joining Roche Diagnostics, Scott earned his MBA through Indiana Wesleyan University in 1999. Scott has worked in various functions within Roche during his nearly 20 years with the company, ranging from lab work in product development to supervising a quality lab to technical support and project management of internationally launched diabetes care product lines. For the past 5+ years, he has worked within the regulatory affairs area supporting the diabetes care product lines produced by Roche. He achieved regulatory affairs certification (RAC) from the Regulatory Affairs Professional Society (RAPS) in 2007. Scott sits on several industry-related groups, including the Combination Product Coalition, AdvaMed Software Working Group, and CLSI Area Committee Point-of-Care. He is also an active participant in the Continua Health Alliance, Regulatory Work Group serving as a co-chair.

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