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# Stakeholders Support Records Guidance
- URL: https://www.fdaweb.com/stakeholders-support-records-guidance/
- Published: 2017-08-22T12:00:00.000Z
- Updated: 2026-09-14T22:42:29.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5139448

AdvaMed says the current 2003 FDA guidance on using electronic records and signatures in medical product clinical investigations is outdated and uses enforcement discretion. In its [comment](https://www.regulations.gov/document?D=FDA-2017-D-1105-0019&ref=fdaweb.com) on a new draft guidance, the trade association says it supports the risk-based approach to validation and audit trails outlined in the draft guidance that will help encourage and support use of modern technologies in medical device clinical trials. It also says it strongly supports the guidance approach to mobile technologies that will facilitate their use in clinical trials by establishing reasonable approaches. The association suggests a number of ways in which it believes the draft could be improved.

Novartis [says](https://www.regulations.gov/document?D=FDA-2017-D-1105-0029&ref=fdaweb.com) that overall, the draft is “pragmatic, forward-looking, and a welcome companion “ to three other documents. It also recommends several changes for FDA to consider.

QuintilesIMS [notes](https://www.regulations.gov/document?D=FDA-2017-D-1105-0042&ref=fdaweb.com) that a parallel guidance was issued for systems used in good manufacturing practice operations and asks the agency to consider identifying common expectations across all good practice areas and note particular or unique expectations for good clinical practice use as a section of the cross good practice guidance.

A Johnson & Johnson comment [letter](https://www.regulations.gov/document?D=FDA-2017-D-1105-0030&ref=fdaweb.com) “welcomes and commends FDA for a thoughtful guidance to aid in adoption of newer technologies, e.g., mobile apps, wearable technologies, and sensors into clinical investigation.” The company says it generally supports the comments submitted by AdvaMed.

Specific line-by-line comments were submitted by [GlaxoSmithKline](https://www.regulations.gov/document?D=FDA-2017-D-1105-0037&ref=fdaweb.com) and [AstraZeneca](https://www.regulations.gov/document?D=FDA-2017-D-1105-0013&ref=fdaweb.com).