ESS ESS USA In-Vitro Diagnostics

Regulatory ESSENTIAL

USA - In-Vitro Diagnostics

Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

In vitro diagnostic; IVD devices; IVD devices; CMDE; Electronic registration; NMPA; UDI regulation; UDI Code; IMDRF; Classification Rule; ISO 15223-1 symbol; vigilance

Scope:	This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostic devices in the USA, based on the - FEDERAL FOOD, DRUG, AND COSMETIC ACT - 21 CFR PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE - FDA Guidances In-Vitro-Diagnostics are regulated under the Medical Device Acts. The main information is provided in: Regulatory ESSENTIAL USA Medical Devices. This ESSENTIAL lists the IVD specific information only.
Stakeholders:	Manufacturer, Importer
Legislation in force:	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
Application national:	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.
Countries:	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)
ROGER WILLCO ID:	#2y66
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Content of this Essential

Scope of this ESSENTIAL

This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostic devices in the USA, based on the
- FEDERAL FOOD, DRUG, AND COSMETIC ACT
- 21 CFR PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
- FDA Guidances

In-Vitro-Diagnostics are regulated under the Medical Device Acts.
The main information is provided in: Regulatory ESSENTIAL USA Medical Devices. This ESSENTIAL lists the IVD specific information only.'

Analysis of regulatory requirements

Legislation in force for this PCT

Here you will get related hyperlink(s)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Legislation in force for this PCT

Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Route to compliance

Formal and administrative requirements

Equipment authorization (approval process)

Hints

Here you will get a image or chart

Specific recommendations, information or most common mistakes

Testing & Standards

Regulatory labelling, markings and user information

Required information on the product and/or packaging

Here you will get related hyperlink(s)

e. g. address of the manufacturer/importer, serial number

General Information:

Code, Continent	USA, North America
Economic Area
Official Language	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.
Standard Institute	American National Standards Institute - ANSI \| https://ansi.org/
HS Codemember	Yes, since 1970

In Vitro Diagnostic (IVD)

USA - United States of America