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U.S. Department of Health and Human Services

Medical Devices

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Code of Federal Regulations - Title 21 - Food and Drugs

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year and is usually available here several months later.

CFR 21 was downloaded from the files of the Government Printing Office (GPO) and contains the most recent revision. The CFR at GPO, both current and historical, can also be searched directly at: http://www.gpoaccess.gov/cfr/index.html.

Search Assistance

There are 3 types of searches that can be done on the CFR Title 21 database.

  1. Search by Part and Section Number- Enter the entire number in the format shown (e.g., 862.1325) and select Search Regulations. This search cannot be combined with any other search. If you enter a Part and Section Number that is not in the current revision of Title 21, you will be given a link to let you search for earlier revisions at GPO.
  1. Select a CFR Part Number- Use the drop down arrow to select one of the CFR Part Numbers for Title 21 and select Search Regulations. Your results will contain a list of all of the Subparts for the Part Number you selected. Choose a Subpart to get the full text of that Subpart. You may also obtain the entire text of the Part Number by choosing the Part link at the top of your results page. This search can be combined with the Full Text Search (#3)
  1. Full Text Search - You may enter a single word (example DEVICE), an exact phrase (example DEVICE TRACKING) or multiple words connected by AND (example import AND export). If you enter an exact phrase, then only items where those words are adjacent to each other in the exact order will be retrieved. If you enter multiple words connected by AND, then the items that are retrieved will contain both of your search words in any order. You may also combine the "Full Text Search" with the "Select a CFR Part Number" search to limit your retrieval to a specific CFR Part Number. Full Text Search uses the Verity Search engine. Help using Verity can be found at Verity-help. Note: The Full Text Search does not include variations of spelling or use of symbols such as hyphens, slashes, etc. If you do not obtain expected results, try variations of your initial search.

Search CFR 21 Database