ROW Image
      

Regulatory ESSENTIAL
USA - Medical Devices

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

Globalnorm Logo
Stakeholders:      Manufacturer, Importer     
Application: USA, Medical Devices, Pre-Market Approval, Pre-Market Notification, Federal Food, Drug, and Cosmetic Act 510(k) requirements, United States Agent
Countries: Image for US USA - United States of America,  
#xy6o  
Status: Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-03-06 by Ina May: Registration at related authority required?, Medical devices
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

expand all        

Subject Areas of this Essential:


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)

General Information:

   USA - United States of America

Code, ContinentUSA, North America
Economic Area
Official LanguageThe 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 InstituteAmerican National Standards Institute - ANSI | https://ansi.org/
HS CodememberYes, since 1970

Price and ordering:

Essentials preview Save a huge amount of time and

licence this REGULATORY ESSENTIAL:

      
 
Mail  Buy a 365 day licence for 695.00 € net now ...
      (opens your default EMail-App)
 
Your personal data will be processed by GLOBALNORM. Further information can be found in our privacy policy.

Further information on Essentials and other services can be found here.
         to top of this document