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Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
DO-178B, Software Considerations in Airborne Systems and Equipment Certification is a guideline dealing with the safety of safety-critical software used in certain airborne systems. It was jointly developed by the safety-critical working group RTCA SC-167 of the Radio Technical Commission for Aeronautics (RTCA) and WG-12 of the European ...
Having obtained a Type Design approval, a manufacturer may need to change the approved design. 14 CFR § 21.93 classifies type design changes as either major or minor. It is the manufacturer's responsibility to first determine and notify the FAA whether a proposed type change is major or minor, subject to FAA review.
For the most uptodate version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).6 New Search Help7 | More About 21CFR 8 [Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2015] [CITE: 21CFR314.50] TITLE 21FOOD AND DRUGS CHAPTER IFOOD AND DRUG ADMINISTRATION
In the case of the USA, for example, that authority is the FAA, and if the FAA finds that the proposed changes are too substantial, a new type certificate will be required under 14 CFR 21.19. In this case, a substantially complete investigation of compliance with the applicable regulations will be required. [1] [2]
It specifically does not require the 21 CFR Part 11 requirement for record retention for trackbacks by food manufacturers. Most food manufacturers are not otherwise explicitly required to keep detailed records, but electronic documentation kept for HACCP and similar requirements must meet these requirements.
An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. [2] The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958 , and all additives introduced after this time had to be evaluated ...
[38] [39] [40] The requirements become more numerous with each successive rating, but most requirements can be "stacked" (i.e. flying cross-country in instrument conditions fulfills both cross-country and instrument hour requirements). Detailed requirements for each rating can be found in 14 CFR Part 61 [41] and in the sections to follow.
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