Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Methodology|Interests|Funding|Corrections
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Bibliographic record

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only —…

United States Food and Drug Administration. FDA Guidance 2013

Document identifier
CEI-BR-024
Series
Bibliographic record
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Bibliographic record

§1.1Record

Authors
United States Food and Drug Administration
Title
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only — Guidance for Industry and FDA Staff
Source
FDA Guidance
Year
2013
Volume, issue, pages
Final guidance
Digital object identifier
not held by the Institute
PubMed identifier
not held by the Institute
Record type
Regulatory document
Institute identifier
CEI-BR-024

§1.2Institute documents citing this record

No Institute document currently cites this record. It is held in the bibliography because it was retrieved during a search and assessed, and the Institute records what it assessed and did not use as well as what it used.

§1.3Subject tags

research-use-only regulatory fda

Compound Evidence Institute · CEI-BR-024 · https://compoundevidence.com/bibliography/fdaruo/ · retrieved 30 July 2026
Nothing published by the Institute is medical advice, a diagnosis, a prescription, a treatment recommendation or a purchasing recommendation. Compounds supplied for research use are not approved for human or veterinary use in any jurisdiction, and a favourable analytical assessment of a supplier is not a statement that any product is safe or effective. The Institute publishes certainty ratings and never recommendations. No telephone number, messaging handle or ordering channel appears anywhere on this site.