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Electronic Code of Federal Regulations

e-CFR data is current as of January 15, 2020

Title 21Chapter ISubchapter HPart 809Subpart A → §809.4


Title 21: Food and Drugs
PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Subpart A—General Provisions


§809.4   Confidentiality of submitted information.

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.

[45 FR 7484, Feb. 1, 1980]

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