Scope: |
This ESSENTIAL describes the regulatory requirements of medical devices in the USA, based on the
- Title 21 - Chapter I - Subchapter H (Medical Devices)
- Federal Food, Drug, and Cosmetic Act
- FDA Official Guides
Definition of "Medical Device" acc. to the Federal Food, Drug, and Cosmetic Act (Chapter II - Definitions)
(h)(1) The term ‘‘device’’ (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals
Health products are classified into three risk classes, according to the classification:
Class I - low risk
Class II - medium risk
Class III - high risk
Radiation-emitting Electronic Products are not in scope of this Regulatory Essential.
|
Legislation in force: |
Title 21 - Food and Drugs
Chapter I - Food and Drug Administration, Department of Health and Human Services
Subchapter H - Medical Devices
FEDERAL FOOD, DRUG, AND COSMETIC ACT
Excerpt of content:
Section 510 - REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES (starts at page 346 of 924)
Section 510(k) REGISTRATION (starts at page 353 of 924)
Section 513 - CLASSIFICATION OF DEVICES INTENDED FOR HUMAN USE (starts at page 392 of 924)
Section 514 - PERFORMANCE STANDARDS (starts at page 407 of 924)
Section 515 - PREMARKET APPROVAL (starts at page 412 of 924)
Section 516 - BANNED DEVICES (starts at page 430 of 924)
Section 517 - JUDICIAL REVIEW
Section 518 - NOTIFICATION AND OTHER REMEDIES
Section 519 - RECORDS AND REPORTS ON DEVICES
Section 520 - GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE
Section 521 - STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES
Section 522 - POSTMARKET SURVEILLANCE
Section 523 - ACCREDITED PERSONS
|