C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 20—PUBLIC INFORMATION › Subpart D—Exemptions

21 C.F.R. § 20.63

Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy

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(a) The names or other information which would identify patients or research subjects in any medical or similar report, test, study, or other research project shall be deleted before the record is made available for public disclosure.

(b) The names and other information which would identify patients or research subjects should be deleted from any record before it is submitted to the Food and Drug Administration. If the Food and Drug Administration subsequently needs the names of such individuals, a separate request will be made.

(c) Requests for deletion of business or product names prior to disclosure of any record to the public shall not be granted on the ground of privacy, but such deletion may be justified under another exemption established in this subpart, e.g., the exemption for trade secrets and confidential commercial or financial information under § 20.61.

(d) Names of individuals conducting investigations, studies, or tests on products or ingredients shall not be deleted prior to disclosure of any record to the public unless extraordinary circumstances are shown.

(e) A request for all records relating to a specific individual will be denied as a clearly unwarranted invasion of personal privacy unless accompanied by the written consent of the individual named.

(f) The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report. This provision does not affect disclosure of the identities of reporters required by a Federal statute or regulation to make adverse event reports. Disclosure of the identities of such reporters is governed by the applicable Federal statutes and regulations.

(1) Exceptions. (i) Identities may be disclosed if both the voluntary reporter and the person identified in an adverse event report or that person's legal representative consent in writing to disclosure, but neither FDA nor any manufacturer in possession of such reports shall be required to seek consent for disclosure from the voluntary reporter or the person identified in the adverse event report or that person's legal representative; or

(ii) Identities of the voluntary reporter and the person who experienced the reported adverse event may be disclosed pursuant to a court order in the course of medical malpractice litigation involving both parties; or (iii) The report, excluding the identities of any other individuals, shall be disclosed to the person who is the subject of the report upon request.

(2) Preemption. No State or local governing entity shall establish or continue in effect any law, rule, regulation, or other requirement that permits or requires disclosure of the identities of the voluntary reporter or other person identified in an adverse event report except as provided in this section.

[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995]
Notes of Decisions
Cited in 29 cases (6 in the last 5 years), 1999–2026 · leading case: In Re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation
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In Re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation (2009) gamd · cites it 26× “, 21 C.F.R. § 20.63 (f); 21 C.F.R. § 20.111 ; 21 C.”
Adcox v. Medtronic, Inc. (1999) ared · cites it 11× “They are clearly not discoverable under Medtronic and 21 C.F.R. § 20.63 (f). (3) Reports made and submitted undef 21 U.”
Caraker v. Sandoz Pharmaceuticals Corp. (2001) ilsd “3944, 3948 (1994) (codified at 21 C.F.R. § 20.63 (f)) (“FDA recognizes the sophistication and complexity of private tort litigation in the United States and the proposed preemption action is not intended to frustrate or impede tort litigation in this area.”
Contratto v. Ethicon, Inc. (2004) cand · cites it 3× “See 21 C.F.R. § 20.63 (f). In proposing section 20.”
In Re: Medtronic, Inc. (1999) ca8 · cites it 3× “Based upon this statutory authority, and to further congressional policy adopted by the Act, the FDA has established a voluntary system of medical device reporting by healthcare professionals, and, in conjunction with this system, has promulgated 21 C.F.R. § 20.63 (f) which…”
Kubicki Ex Rel. Kubicki v. Medtronic (2014) dcd · cites it 2× “Under an FDA regulation, codified at 21 C.F.R. § 20.63 , manufacturers are prohibited from disclosing “[t]he names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical…”
Custer v. C R Bard Incorporated (2020) nvd · cites it 4× “To the extent that Defendants 10 are able to identify whether these reports and complaint files relate to the Plaintiff at the time 11 they are produced in This Action, the parties and their respective counsel have consented to 12 and agreed that the Defendants shall refrain…”
Howmedica Osteonics Corp. v. Trowbridge (2017) fladistctapp · cites it 3× “See 21 C.F.R. § 20.63 (f) (2016). This petition arises from a consolidated proceeding pending in the trial court involving many plaintiffs who allege they sustained personal injuries from hip-implant medical devices manufactured by HOC that were subsequently recalled.”
Jinna E. Miller v. Abbott Laboratories (2023) cacd · cites it 2× “ned herein to include information that is not in the public domain and contains 6 employee information, financial data and information, and any other information 7 that may reasonably be characterized by a party as intellectual property, a trade 8 secret, or confidential and…”
Dreger v. KLS Martin, LP (2023) ohsd · cites it 2× “21 C.F.R. § 20.63 . As previously discussed, Defendant is a “manufacturer” for purposes of medical device reporting.”
Bjornstad v. Ethicon Endo-Surgery LLC (2020) wawd · cites it 2× “The names and addresses of patients and physicians shall be redacted, as well as all identifying information regarding the 8 reporters in such a manner as not to redact material data contained in such reports and consistent with the requirements of 21 C.F.R. 20.63(f). 9…”
In Re: Medtronic Inc v. (1999) ca8 · cites it 3× “-2- Based upon this statutory authority, and to further congressional policy adopted by the Act, the FDA has established a voluntary system of medical device reporting by healthcare professionals, and, in conjunction with this system, has promulgated 21 C.F.R. § 20.63 (f) which…”
Show all 29 citing cases →
— 21 C.F.R. § 20.63(a) — 1 case
Dreger v. KLS Martin, LP (2023) ohsd “21 C.F.R. § 20.63 . As previously discussed, Defendant is a “manufacturer” for purposes of medical device reporting.”
— 21 C.F.R. § 20.63(f) — 3 cases
Adcox v. Medtronic, Inc. (1999) ared “They are clearly not discoverable under Medtronic and 21 C.F.R. § 20.63 (f). (3) Reports made and submitted undef 21 U.”
Bjornstad v. Ethicon Endo-Surgery LLC (2020) wawd “The names and addresses of patients and physicians shall be redacted, as well as all identifying information regarding the 8 reporters in such a manner as not to redact material data contained in such reports and consistent with the requirements of 21 C.F.R. 20.63(f). 9…”
In Re: Medtronic Inc v. (1999) ca8 “-2- Based upon this statutory authority, and to further congressional policy adopted by the Act, the FDA has established a voluntary system of medical device reporting by healthcare professionals, and, in conjunction with this system, has promulgated 21 C.F.R. § 20.63 (f) which…”
— 21 C.F.R. § 20.63(f)(1) — 1 case
Adcox v. Medtronic, Inc. (1999) ared “They are clearly not discoverable under Medtronic and 21 C.F.R. § 20.63 (f). (3) Reports made and submitted undef 21 U.”
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