FDA Updates Part 11 Guidance for Clinical Trials to Include Mobile and Wearable Tech

Public Comments are invited until late August 2017

The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting.

In a question-and-answer format, the guidance builds on the FDA’s 2003 Part 11 guidance, explaining how drug sponsors, contract research organizations, institutional review boards and other clinical trial entities must validate systems and audit trails to ensure data integrity.

The guidance suggests using a risk-based approach to validating individual technologies and calls on sponsors to thoroughly examine any product that provides clinical data, such as a wearable sensor that measures blood glucose levels.

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