GroundRules
21 CFR 809.4: Confidentiality of submitted information.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
- Subpart A—General Provisions
Data and information submitted under § 809.10(c) that are shown to fall within the exemption established in § 20.61 of this chapter shall be treated as confidential by the Food and Drug Administration and any person to whom the data and information are referred. The Food and Drug Administration will determine whether information submitted will be treated as confidential in accordance with the provisions of part 20 of this chapter.
Collected 2026-08-27T02:24:47Z. Source file · JSON