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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR807.34]
See Related Information on Summary of requirements for owners or operators granted a waiver from submitting required information electronically. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 807 -- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

Subpart B--Procedures for Device Establishments

Sec. 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.

(a) For initial registration and listing, owners or operators who have been granted a waiver from electronic filing using the procedures set forth in 807.21(b) must send a letter containing all of the registration and listing information described in 807.22, 807.25, (and 807.26 when such information is requested by FDA), at the times described in 807.22, to: The Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002.

(b) As specified in 807.22(b)(1) and (b)(3), all owners or operators shall update their establishment registration and device listings annually during the period beginning on October 1 and ending on December 31 of each fiscal year.

(c) Failure to submit any of the required information on time, as specified in 807.22(a) and (b), will put the establishment in a "failed to register" or "failed to list" status as applicable.

The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until the required information is submitted to and processed by FDA.

[77 FR 45943, Aug. 2, 2012]

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