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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 21Chapter ISubchapter HPart 806Subpart B → §806.40


Title 21: Food and Drugs
PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
Subpart B—Reports and Records


§806.40   Public availability of reports.

(a) Any report submitted under this part is available for public disclosure in accordance with part 20 of this chapter.

(b) Before public disclosure of a report, FDA will delete from the report:

(1) Any information that constitutes trade secret or confidential commercial or financial information under §20.61 of this chapter; and

(2) Any personnel, medical, or similar information, including the serial numbers of implanted devices, which would constitute a clearly unwarranted invasion of personal privacy under §20.63 of this chapter or 5 U.S.C. 552(b)(6); provided, that except for the information under §20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will disclose to a patient who requests a report all the information in the report concerning that patient.

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