Anwendungsbereich des Regulatory Essentials
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.
Manufacturer, Importer, B2C products, B2B products
Geltende Rechtsvorschriften:
Title 21 - Food and Drugs
Chapter I - Food and Drug Administration, Department of Health and Human Services
Subchapter H - Medical Devices
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 of 924)
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
Section 518 - NOTIFICATION AND OTHER REMEDIES
Section 519 - RECORDS AND REPORTS ON DEVICES
Section 520 - GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE
Section 521 - STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES
Section 522 - POSTMARKET SURVEILLANCE
Section 523 - ACCREDITED PERSONS
Nationale Anwendungsebene:
USA, Medical Devices, Pre-Market Approval, Pre-Market Notification, Federal Food, Drug, and Cosmetic Act 510(k) requirements, United States Agent
USA - United States of America
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2025-11-19 by Torsten Sahm: Abbreviations, Medical devices
Inhalt des Regulatory Essentials
| Responsible actors |
Hier erhalten Sie textbasierte Informationen
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)?
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| Regulatory market access conditions for the actor(s) |
Hier erhalten Sie textbasierte Informationen
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)
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| Exemption clauses |
Hier erhalten Sie textbasierte Informationen
Exempted devices/products or industry sectors.
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| Sub-federal legislation of states/counties |
Hier erhalten Sie textbasierte Informationen
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.
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| FTA/MRA status with EU |
Hier erhalten Sie zugehörige weiterführende Links
Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?
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| Authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for approval, registration, market surveillance and/or enforcement
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| Market surveillance authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for market surveillance and/or enforcement
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| Link/Reference to other reference document(s) |
Hier erhalten Sie zugehörige weiterführende Links
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| Comment on the comparability to EU legislation |
Hier erhalten Sie textbasierte Informationen
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| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
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Formal and administrative requirements
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| Registration at related authority required? |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Local representative legally required? |
Hier erhalten Sie textbasierte Informationen
[Yes/No]
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| IMDRF Membership |
Hier erhalten Sie textbasierte Informationen
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.
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| Database Entry required |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
|
| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
|
Equipment authorization (approval process)
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| Classification Rules |
Hier erhalten Sie zugehörige weiterführende Links
|
| Nomenclature/Borderline Rules |
Hier erhalten Sie zugehörige weiterführende Links
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| Approval process (conformity assessment procedure) |
Hier erhalten Sie ein Foto oder Diagram
Means each legally required approval process prior placing on the market, importation or putting into service
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| Approval process (conformity assessment procedure) |
Hier erhalten Sie zugehörige weiterführende Links
Means each legally required approval process prior placing on the market, importation or putting into service
|
| Approval process (conformity assessment procedure) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
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 |
Hier erhalten Sie textbasierte Informationen
e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)
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| Conformance document validity and renewal |
Hier erhalten Sie zugehörige weiterführende Links
Validity for Conformance document name mentioned. For mandatory certification validity is important.
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| Which documents are required by an approval body? |
Hier erhalten Sie zugehörige weiterführende Links
e .g. formal application
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| Is a factory inspection legally required |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier erhalten Sie ein Foto oder Diagram
Specific recommendations, information or most common mistakes
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| Specific requirements for testing |
Hier erhalten Sie textbasierte Informationen
e. g. is an accredited test lab. mandatory, limits, test samples, product description
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| General information to the application of standards |
Hier erhalten Sie textbasierte Informationen
e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"
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| Source for standards for conformity assessment |
Hier erhalten Sie zugehörige weiterführende Links
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| National Standardisation Organisation |
Hier erhalten Sie zugehörige weiterführende Links
Link to organisation
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| Are national standards based on IEC/ISO standards? |
Hier erhalten Sie textbasierte Informationen
Undetailed information
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| Clinical Investigation/Evaluation |
Hier erhalten Sie zugehörige weiterführende Links
|
| Is in-country testing legally required? |
Hier erhalten Sie textbasierte Informationen
|
| Acceptance of foreign test reports |
Hier erhalten Sie textbasierte Informationen
|
Regulatory labelling, markings and user information
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| Regulatory label (mandatory) |
Hier erhalten Sie textbasierte Informationen
e. g. product label
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| Regulatory e-labelling allowed? |
Hier erhalten Sie textbasierte Informationen
e. g. put the regulatory information and labels in a software menu
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| UDI marking |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
|
| Required information on the product and/or packaging |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
e. g. address of the manufacturer/importer, serial number
|
| User instructions language(s) |
Hier erhalten Sie textbasierte Informationen
Regulated by the legal provisions
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| User instruction requirements and specific compliance notes |
Hier erhalten Sie textbasierte Informationen
Form, sentence inside, simple text.
E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste
|
| Medical Device Symbols |
Hier erhalten Sie zugehörige weiterführende Links
|
Allgemeine Informationen
USA - United States of America
Code, Kontinent, Wirtschaftsraum
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.
American National Standards Institute - ANSI | https://ansi.org/
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