1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 803 - MEDICAL DEVICE REPORTING
  6. Subpart A - General Provisions
  7. 21 CFR § 803.13
21 CFR § 803.13
Do I need to submit reports in English?
June 25, 2020
CFR

Yes. You must submit all reports required by this part in English.

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§ 803.12 How do I submit initial and supplemental or followup reports?
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§ 803.15 How will I know if you require more information about my medical device report?

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