Meaning to close by folding or bringing together is from mid-14c. Sense of to set (someone) free (from) (c.1500) is obsolete except in dialectal phrases such as to get shut of. Colloquial shut-eye for sleep is from 1899. To shut (one's) mouth desist from speaking is recorded from 1340.
Medical Device Regulation Act. Medical Device Amendments of 1976. An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes. Enacted by.
A PMA is required for FDA Approval of medical devices that present significant risk to the patient and/or require significant scientific review of the safety and effectiveness of the medical device prior to commercial introduction. Most Class III medical devices require a PMA.