Code of Federal Regulations 21 Parts 800 to 1299 Food and Drugs: Revised as of April 1 2006U.S. Government Printing Office, 2006 - 786 lappuses The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government. This volumwe contains the regulations about medical devices. |
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1 For nomenclature changes to chapter I see 59 FR 14366 Mar 28 1994 | 3 |
Part Page 800 General | 5 |
Labeling | 13 |
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accessories accordance amended amended at 65 ance standards application approval blood body caused chapter subject Class II perform Class II special Classification clinical commercial distribution completion component consists container designed determine device intended device is exempt diagnosis disease document effective electrical equipment established evaluation facility Federal files Food and Drug Guidance hearing human Identification implanted indicate joint July 25 June labeling limitations manufacturer material means measure ment monitor notice operation paragraph patient person placed powered practice premarket notification procedures procedures in subpart prosthesis radiation reagents reasonable records regulation request respect safety Sept serum special controls specific statement submit subpart E surgical test system tion tissue treatment trols tube unit unless vice x-ray