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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: 21CFR803.15]
See Related Information on How will I know if you require more information about my medical device report? 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 803 -- MEDICAL DEVICE REPORTING

Subpart A--General Provisions

Sec. 803.15 How will I know if you require more information about my medical device report?

(a) We will notify you in writing if we require additional information and will tell you what information we need. We will require additional information if we determine that protection of the public health requires additional or clarifying information for medical device reports submitted to us and in cases when the additional information is beyond the scope of FDA reporting forms or is not readily accessible to us.

(b) In any request under this section, we will state the reason or purpose for the information request, specify the due date for submitting the information, and clearly identify the reported event(s) related to our request. If we verbally request additional information, we will confirm the request in writing.

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