Flashcards in Ch 19 P 14 Devices Deck (6)
As used in the New Mexico Drug and Cosmetic Act, is any health care product that does not achieve any of its principal intended purpose through chemical action within or on the body of man or other animal and which is not dependent upon being metabolized for achievement of any of its principal intended purposes.
Class I - General controls
(1) prohibiting adulteration or misbranding
(2) requiring federal registration and listing by the manufacturer
(3) requiring notification of risks, repairs, replacement or refund
(4) requirement restricting sale, distribution or use
(5) requirement with respect to good manufacturing practices, record keeping, reports and inspections
(6) authority to ban the device
Class II - Performance standards
(1) general controls not sufficient to assure safety and effectiveness
(2) performance standards required by federal FDA
Class III - Pre-market Approval
(1) represents life sustaining, life-supporting or implanted in the body or which presents a potential unreasonable risk of illness or injury.
(2) requires investigational device exemption for research (IDE under federal act Sec. 520 (g)).
A device may be considered to be adulterated if
A. It is subject to a performance standard and does not comply with all requirements of such standard.
B. Class II device FDA pre-market approval is not completed
C. It is a banned device.
D. It is in violation of good manufacturing practice requirements.
E. It fails to comply with the IDE (Investigational device exemption) protocol