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# Stakeholders Appreciate IVD Draft Guidance
- URL: https://www.fdaweb.com/stakeholders-appreciate-ivd-draft-guidance/
- Published: 2018-03-29T12:00:00.000Z
- Updated: 2026-09-14T23:56:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141104

Three industry stakeholders say they appreciate an FDA draft guidance on investigational IVDs (*in vitro* diagnostics) and suggest changes they would like in the draft. The Biotechnology Innovation Organization (BIO) says in a 3/19 comment [letter](https://www.regulations.gov/document?D=FDA-2017-N-6356-0011&ref=fdaweb.com) that it appreciates that the guidance provides several examples of IVD uses that are considered to be investigational, such as identifying subjects for study enrollment criteria, predicting increased or decreased risk for serious adverse events from the therapeutic product, determining appropriate dosing levels/amounts, and others. However, it continues, its members would benefit from additional clarification in what would constitute a non-investigational device study that would fall outside the scope of IDE requirements. The letter lists additional areas for which BIO would like further clarification.

AdvaMedDx [says](https://www.regulations.gov/document?D=FDA-2017-N-6356-0009&ref=fdaweb.com) it applauds inclusion in the draft of examples of how IVDs, both assays and software, are used in therapeutic product clinical trials. “We would appreciate an extended, comprehensive list of the known types of uses of IVDs in therapeutic product trials and clear instruction as to whether certain uses are considered investigational,” it says. The comment also asks that the agency cross-reference other relevant guidances in the final guidance.

In its response, Merck offers one [comment](https://www.regulations.gov/document?D=FDA-2017-N-6356-0010&ref=fdaweb.com) on invasive blood sampling, asking FDA to reconsider including biopsy procedures for the purposes of significant risk determination for oncology trials and similar therapeutic areas