Regulatory ESSENTIAL
USA - Medical Devices

Scope of this ESSENTIAL

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.'

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)?

Responsible actors

here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

here you will get textual information What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

here you will get textual information Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

here you will get textual information E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

here you will get related hyperlink(s) Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

here you will get related hyperlink(s) Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

here you will get related hyperlink(s)

Abbreviations

here you will get textual information Important abbreviations which are special for this legislation or theme.

Route to compliance

Formal and administrative requirements

Registration at related authority required?

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

here you will get textual information [Yes/No]

IMDRF Membership

here you will get textual information Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Database Entry required

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence)

Equipment authorization (approval process)

Classification Rules

here you will get related hyperlink(s)

Nomenclature/Borderline Rules

here you will get related hyperlink(s)

Approval process (conformity assessment procedure)

here you will get a image or chart Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

here you will get related hyperlink(s) Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority

here you will get textual information e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal

here you will get related hyperlink(s) Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?

here you will get related hyperlink(s) e .g. formal application

Is a factory inspection legally required

here you will get textual information

Hints

here you will get a image or chart Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing

here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards

here you will get textual information e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment

here you will get related hyperlink(s)

Clinical Investigation/Evaluation

here you will get related hyperlink(s)

Is in-country testing legally required?

here you will get textual information

Acceptance of foreign test reports

here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)

here you will get textual information e. g. product label

Regulatory e-labelling allowed?

here you will get textual information e. g. put the regulatory information and labels in a software menu

UDI marking

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence)

Required information on the product and/or packaging

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) e. g. address of the manufacturer/importer, serial number

User instructions language(s)

here you will get textual information Regulated by the legal provisions

User instruction requirements and specific compliance notes

here you will get textual information Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Medical Device Symbols

here you will get related hyperlink(s)

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