NMBOP:16.19.14 DEVICES Flashcards
“Device”
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.
“Medical gas”
“Medical gas” means:
(1) a drug that is manufactured or stored in a liquefied, nonliquefied, or cryogenic state and is administered as a gas; and
(2) that is labeled for medical use in compliance with federal law and is otherwise a designated medical gas as defined at 21 U.S.C. Section 360ddd(1) of the Federal Act, including each of the following that meets the standards set forth in an official compendium: oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, and medical air.
“Medical gas repackager”
means a person that manufactures or repackages a medical gas, which includes producing, cascading, distributing, filling, mixing, purifying, separating, transferring, and transfilling medical gases. This includes original manufacturers as defined by the FDA that repackage medical gas and have a valid registration as a drug establishment with the FDA. A medical gas manufacturer shall be issued the license type medical gas repackager.
“Medical gas seller”
means a person licensed to distribute a medical gas to a person other than a consumer or patient, or to supply medical gases on drug orders to a patient or ultimate user.
“Repackage”
“Repackage” means persons or entities manufacturing bulk medical gases or transferring gas or liquefied gas product from one container to another (e.g., liquid to gas, gas to gas, liquid to liquid).
CLASSIFICATION OF DEVICES:
Q: What is the classification of devices based on regulatory control?
A: Three regulatory classes are established based on the extent of control necessary to ensure safety and effectiveness of each device.
CLASSIFICATION OF DEVICES:
Q: What are the characteristics of Class I devices?
A:
1. General Controls
2. Prohibiting adulteration or misbranding
3. Requiring federal registration and listing by the manufacturer
4. Requiring notification of risks, repairs, replacement, or refund
5. Requirement restricting sale, distribution, or use
6. Requirement with respect to good manufacturing practices, record keeping, reports, and inspections
7. Authority to ban the device
CLASSIFICATION OF DEVICES:
Q: What are the characteristics of Class II devices?
A:
1. Performance Standards
2. General controls not sufficient to assure safety and effectiveness
3. Performance standards required by federal FDA
4. FDA regulations establishing the performance standard
CLASSIFICATION OF DEVICES:
Q: What are the characteristics of Class III devices?
A:
1. Pre-Market Approval
2. Represents life sustaining, life-supporting, or implanted in the body or which presents a potential unreasonable risk of illness or injury
3. Requires investigational device exemption for research (IDE under federal act Sec. 520 (g))
ADULTERATION: A device may be considered to be adulterated:
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.
MISBRANDING: A device may be deemed to be misbranded if:
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.
Restricted Devices
Q: Under what condition may the FDA restrict the sale, distribution, or use of a device?
A: If there cannot be reasonable assurance of its safety and effectiveness.
Restricted Devices
Q: How is prescription status for devices determined?
A: Prescription status devices are determined based on its intended use and whether or not the device can be adequately labeled as usable by the layman (e.g., pacemaker, hearing aids, heart valves, etc.).
Restricted Devices
Q: What information must labeling of a restricted device contain?
A: Labeling must contain the name of the device, a statement of intended use, relevant warnings, precautions, side effects, and contraindications.
Restricted Devices
Q: What must the labeling of a restricted device, other than surgical instruments, bear?
A: The labeling must bear:
- “CAUTION: Federal law restricts this device to sale by or on the order of a ______:” (e.g., physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the laws of this State to prescribe or use the device in his practice).
- The method of its application or use.
CUSTOM DEVICES
Q: What is a custom device?
A: A custom device is one that is sometimes ordered from manufacturers by practitioners to conform to their own special needs or to those of their patients (e.g., prosthetic devices, dental devices, and specially designed orthopedic footwear).
CUSTOM DEVICES
Q: Are custom devices subject to performance standards or pre-market approval requirements?
A: No, custom devices are exempt from performance standards or pre-market approval requirements. However, they are subject to FDA requirements for investigational use, banning, restriction of distribution, adulteration, and misbranding.
CUSTOM DEVICES
Q: What is the limitation of the exemption for custom devices?
A: The exemption applies only to devices which are not generally available in finished form for dispensing, or on prescription, or for commercial distribution, or generally available to other practitioners.
