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# ‘Real-World’ Guidance Needs FDA Openness: Attorneys
- URL: https://www.fdaweb.com/real-world-guidance-needs-fda-openness-attorneys/
- Published: 2016-08-04T12:00:00.000Z
- Updated: 2026-09-14T21:21:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136398

Four Hogan Lovells attorneys say that the success of a recent FDA draft [guidance](https://www.fdaweb.com/real-world-evidence-guidance-out/) on using real-world evidence to support regulatory decision-making for medical devices will depend on the agency’s openness to accepting proposed real-world evidence despite its limitations. Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=5c7a3b17-1cd4-403d-9167-b2adfb8e87cc&ref=fdaweb.com), the four say that the guidance is intended to clarify when real-world evidence can be used in agency decision making and reaffirms that such evidence retains a place in the medical device regulatory landscape. They say the document will undoubtedly be well received by industry.

“While the draft guidance does not appear to implement significant, concrete policy changes, it does provide tangible recognition by FDA of the multitude of non-traditional data sources that may contribute to a meaningful understanding of medical device safety and effectiveness,” the post says.

The guidance includes what the attorneys describe as a “detailed discussion” of the specific criteria by which the agency will appraise real-world data and real-world evidence intended to be used to evaluate a regulatory issue. Primary among the criteria are the relevance and reliability of the data, they say. The document also has several examples of actual uses of real-world evidence for regulatory decision-making.

“The draft guidance represents tangible recognition by FDA of the multitude of data sources that exist in developing supportive data for medical device development, validation, and ongoing improvement” the post concludes, “and expresses a willingness to collaborate with industry to use this data for medical advancement and patient benefit (e.g., to expedite access to devices for unmet needs) without forgoing established regulatory protections. Even while a substantial proportion of real-world evidence is unlikely to meet the acceptance criteria set forth by FDA, the guidance thus reaffirms that real-world evidence retains a place in the medical device regulatory landscape. If companies have particular real-world evidence which they believe can answer a specific regulatory question, FDA will consider its suitability.”