Get 21 CFR Ch. I (4 1 09 Edition) 814.118 - Edocket Access Gpo

General Labeling Provisions. The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in this chapter discuss any additional requirements needed for specific categories of devices.

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.

(a) This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

21 CFR Part 210 - PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL. § 210.1 Status of current good manufacturing practice regulations. § 210.2 Applicability of current good manufacturing practice regulations.

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.

The Code of Federal Regulations (CFR) is an annual codification of the general and permanent rules of the executive departments and agencies of the Federal Government published by the Office of the Federal Register (OFR) in the National Archives and Records Administration (NARA) in the Federal Register.

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government.