§ 812.7 Prohibition of promotion and other practices

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.

(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.

(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 812.7

Form FDA 483 observations citing this section, fiscal years 2010–2025 (Devices).

• Promotion or test marketing 10
• Investigational device represented as safe and /or effective 4
• Commercialization 2

Warning letters citing § 812.7

2 FDA warning letters since 2017 cite this section :

• ExThera Medical Corporation 6 Feb 2026
• Zona Health Inc. 6 Dec 2019

FDA guidance that cites § 812.7

• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry draft 2 Jun 2026
• Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors 15 Aug 2023
• Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders 26 Jan 2022
• Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff 6 Sept 2019
• Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff 11 Jul 2019
• Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff draft 15 Jul 2016
• Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff 25 Nov 2013
• IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors 27 Feb 2012
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff 14 Jul 2011
• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff 25 Jun 2010
• Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry 23 Oct 2009
• Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators 1 Jan 1998

Amendment history

Federal Register documents that created or amended this section.

• 45 FR 3751 18 Jan 1980