e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

 

Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter HPart 812Subpart C → §812.47


Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart C—Responsibilities of Sponsors


§812.47   Emergency research under §50.24 of this chapter.

(a) The sponsor shall monitor the progress of all investigations involving an exception from informed consent under §50.24 of this chapter. When the sponsor receives from the IRB information concerning the public disclosures under §50.24(a)(7)(ii) and (a)(7)(iii) of this chapter, the sponsor shall promptly submit to the IDE file and to Docket Number 95S-0158 in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, copies of the information that was disclosed, identified by the IDE number.

(b) The sponsor also shall monitor such investigations to determine when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in §50.24(a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall provide this information in writing to FDA, investigators who are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that are asked to review this or a substantially equivalent investigation.

[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999]

Need assistance?