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The purpose of an IDE under 21 CFR Part 812 is to encourage the discovery and development of useful devices, with the proviso that “protection of the public health and safety” is preserved. FDA wants revolutionary new devices to be tested, as long as safety and ethics are kept a priority.

(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's).

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

21 CFR Part 11 provides an opportunity for medical device companies to reap the organizational benefits of paperless record-keeping systems. It also helps the FDA ensure that when medical device companies use electronic record-keeping systems, that document security and authenticity are adequately maintained.

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.

Under 21 CFR 312.32(c), as it currently exists, a sponsor must provide expedited reporting to FDA and to all participating investigators of any “suspected adverse reaction that is both serious and unexpected” (a serious and unexpected suspected adverse reaction (SUSAR)).

The purpose of an IDE under 21 CFR Part 812 is to encourage the discovery and development of useful devices, with the proviso that “protection of the public health and safety” is preserved. FDA wants revolutionary new devices to be tested, as long as safety and ethics are kept a priority.

21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted ing to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the ...