CFR

Title 1 - General Provisions
Title 2 - Grants and Agreements
Title 3 - The President
Title 4 - Accounts
Title 5 - Administrative Personnel
Title 6 - Domestic Security
Title 7 - Agriculture
Title 8 - Aliens and Nationality
Title 9 - Animals and Animal Products
Title 10 - Energy
Title 11 - Federal Elections
Title 12 - Banks and Banking
Title 13 - Business Credit and Assistance
Title 14 - Aeronautics and Space
Title 15 - Commerce and Foreign Trade
Title 16 - Commercial Practices
Title 17 - Commodity and Securities Exchanges
Title 18 - Conservation of Power and Water Resources
Title 19 - Customs Duties
Title 20 - Employees' Benefits
Title 21 - Food and Drugs
Title 22 - Foreign Relations
Title 23 - Highways
Title 24 - Housing and Urban Development
Title 25 - Indians
Title 26 - Internal Revenue
Title 27 - Alcohol, Tobacco Products and Firearms
Title 28 - Judicial Administration
Title 29 - Labor
Title 30 - Mineral Resources
Title 31 - Money and Finance: Treasury
Title 32 - National Defense
Title 33 - Navigation and Navigable Waters
Title 34 - Education
Title 35 - Panama Canal
Title 36 - Parks, Forests, and Public Property
Title 37 - Patents, Trademarks, and Copyrights
Title 38 - Pensions, Bonuses, and Veterans' Relief
Title 39 - Postal Service
Title 40 - Protection of Environment
Title 41 - Public Contracts and Property Management
Title 42 - Public Health
Title 43 - Public Lands: Interior
Title 44 - Emergency Management and Assistance
Title 45 - Public Welfare
Title 46 - Shipping
Title 47 - Telecommunication
Title 48 - Federal Acquisition Regulations System
Title 49 - Transportation
Title 50 - Wildlife and Fisheries

803.53—If I am a manufacturer, in which circumstances must I submit a 5-day report?

You must submit a 5-day report to us, on Form 3500A or an electronic equivalent approved under § 803.14, no later than 5 work days after the day that you become aware that:

(a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis; or

(b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.

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