C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS › Subpart G—Records and Reports

21 C.F.R. § 812.145

Inspections

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept).

(b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.

(c) Records identifying subjects. An investigator shall permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading.

Notes of Decisions
Cited in 2 cases, 1996–1996 · leading case: Berish v. Richards Med. Co., 937 F. Supp. 181 (N.D.N.Y. 1996).
Sort: Relevance Newest Treatment
Berish v. Richards Med. Co., 937 F. Supp. 181 (N.D.N.Y. 1996). “100 (responsibilities of investigators); 21 C.F.R. § 812.145 (inspections); 21 C.F.”
Berish v. Richards Med. Co., 928 F. Supp. 185 (N.D.N.Y. 1996). “100 (responsibilities of investigators); 21 C.F.R. § 812.145 (inspections); 21 C.F.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.