Stakeholder:

Manufacturer, Importer

Geltende Rechtsvorschriften:

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) 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 (431 Section 518 - NOTIFICATION AND OTHER REMEDIES (433 Section 519 - RECORDS AND REPORTS ON DEVICES Section 520 - GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE (447 Section 521 - STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES Section 522 - POSTMARKET SURVEILLANCE Section 523 - ACCREDITED PERSONS Title 21 - Chapter I - Subchapter H (Medical Devices) - Part 809 PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE § 809.3 Definitions (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act. Title 21 - Chapter I - Subchapter H - Part 862 PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Title 21 - Chapter I - Subchapter H - Part 864 PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

Nationale Anwendungsebene:

USA, Medical Devices, Pre-Market Approval, Pre-Market Notification, Federal Food, Drug, and Cosmetic Act 510(k) requirements. Main requirements are described in: Regulatory Essential USA Medical Devices.

Länder:

USA - United States of America

Status:

Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-08-11 by Anette Dunkel-Reinboth: Scope of this ESSENTIAL, In Vitro Diagnostic (IVD)

ID:

#2y66

Code, Kontinent, Wirtschaftsraum

USA, North America

Wirtschaftsraum

Offizielle Amtssprache

The United States of America doesn’t have an official language on the federal level. They do use English as the primary language for official documents and publications, legislation, orders, regulations and rulings. The states with English as the only official language are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, South Carolina, South Dakota, Tennessee, Utah, Virginia and Wyoming. Puerto Rico has declared Spanish the principal language, but both English and Spanish are official languages. In the US Virgin Islands, only English is official, while American Samoa has English and Samoan. Guam has English and Chamorro has official languages and in the Northern Mariana Islands, English, Chamorro and Carolinian are official.

Normen Institut

American National Standards Institute - ANSI | https://ansi.org/

HS Codemitglied

Yes, since 1970