Ch 19 P 14 Devices

Question 1

Device

Answer 1

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.

Question 2

Class I - General controls

Answer 2

(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

Question 3

Class II - Performance standards

Answer 3

(1) general controls not sufficient to assure safety and effectiveness
(2) performance standards required by federal FDA

Question 4

Class III - Pre-market Approval

Answer 4

(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)).

Question 5

A device may be considered to be adulterated if

Answer 5

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

Question 6

A device may be considered to be misbranded if

Answer 6

A. Manufactured in a nonregistered establishment pursuant to federal requirements.
B. If advertising and description literature fails to meet minimum requirements for disclosure of product information.
C. Devices subject to performance standards set by FDA, whose labeling fails to meet those prescribed in the standard.
D. Devices that fail or whose manufacturer refuses to comply with requirements relating to notification and other remedies and requirements or fails to maintain adequate records and necessary reports as required under the federal act Section 518-519.
E. If its label does not bear adequate directions for use and adequate warning against unsafe use.
F. If the labeling is false or misleading.
G. If it is a restricted device and fails to bear required labeling.