Regulatory ESSENTIAL
USA - In-Vitro Diagnostics

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 licence) 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

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