> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Improving Real-World Evidence Guidance
- URL: https://www.fdaweb.com/improving-real-world-evidence-guidance/
- Published: 2016-10-27T12:00:00.000Z
- Updated: 2026-09-14T21:43:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137196

The Small Biotechnology Business Coalition [commends](https://www.regulations.gov/document?D=FDA-2016-D-2153-0030&ref=fdaweb.com) FDA for its 7/27 draft guidance on using data and evidence collected outside of the traditional clinical trial context to support medical device regulatory decisions. The group suggests these additions to improve the impact and clarity of the draft: 

- stipulating that economic cost-benefit analysis should be given significant weight by FDA when deciding whether to accept real-world evidence or prospective data or traditional clinical trials;
- initiating of a pilot program with the Centers for Medicare and Medicaid Services (CMS) to permit joint review of real-world evidence for both FDA approval and a CMS coverage determination; and
- permitting use of real-world evidence from overseas.

The 510(k) Coalition [says](https://www.regulations.gov/document?D=FDA-2016-D-2153-0024&ref=fdaweb.com) it believes the draft relies too heavily on registries and does not use non-registry sources of real-world evidence sufficiently. The group says it also believes that the draft “does not provide clear enough criteria for when and how to use real-world evidence for regulatory decision-making, nor does it include reference to least burdensome methods of data collection/analysis.”

In other comments, the coalition says that the draft relies too heavily on the pre-submission process or prior approval, and is not clear enough on the use of different types of real-world evidence and real-world data. Finally, it says it is important that the final guidance include combination products and apply to the device portion of combination products, whether under CDER or CBER.