CFR

Title 1 - General Provisions
Title 2 - Grants and Agreements
Title 3 - The President
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Title 5 - Administrative Personnel
Title 6 - Domestic Security
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Title 14 - Aeronautics and Space
Title 15 - Commerce and Foreign Trade
Title 16 - Commercial Practices
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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
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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

820.200—Servicing.

(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

(b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with § 820.100.

(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.

(d) Service reports shall be documented and shall include:

(1) The name of the device serviced;

(2) Any device identification(s) and control number(s) used;

(3) The date of service;

(4) The individual(s) servicing the device;

(5) The service performed; and

(6) The test and inspection data.

Code of Federal Regulations

[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004]

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