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USA - United States of America
ESS USA Medical Devices Cybersecurity
IT; OT; Operational technology (OT) controls devices; Information technology (IT) controls data; Threat modelling; Threat modeling; vulnerability; incident; handling; ISMS; data privacy; security asset; network asset, privacy asset; financial asset

89.00 € NET

30-Tages-Lizenz

Anwendungsbereich des Regulatory Essentials

Stakeholder:

Manufacturer, Importer, B2C products, B2B products

Geltende Rechtsvorschriften:

DATA PROTECTION LAW (FEDERAL) EU: The comprehensive law in the EU is "General Data Protection Regulation" (GDPR). USA: The United States don't have an equivalent comprehensive law that covers the privacy of all types of data. US-States: Comprehensive laws already existing in a few states. On federal level, only specific types of data in certain circumstances are covered by laws as given below: - Health Insurance Portability and Accountability Act (HIPAA) which covers communication - Fair Credit Reporting Act (FCRA) which covers data in credit report - Family Educational Rights and Privacy Act (FERPA) which covers data in education records maintained by a school. - Gramm-Leach-Bliley Act (GLBA) which covers data in consumer financial products - Electronic Communications Privacy Act (ECPA) which covers law enforcement access to data - Children’s Online Privacy Protection Rule (COPPA) which covers company’s data collection for children under age of 13 years - Video Privacy Protection Act (VPPA) which covers VHS rental records - Federal Trade Commission Act (FTC Act) which covers the FTA empowerment to investigation INTERNET OF THINGS (IoT) The most relevant standardization conformity program will result out of: Executive Order 14028 of May 12, 2021. Aim: Improving the Nation's Cybersecurity. Status: NIST standards are in the making. The Cybersecurity Information Sharing Act (CISA) is a United States federal law that seeks to "enhance cybersecurity in the United States through increased sharing of cybersecurity threat information, and for other purposes." DATA PROTECTION LAW (STATES) Currently, three states in the US have three different comprehensive consumer privacy laws: Colorado (ColoPA), Virginia (VCDPA), and California (CCPA and its amendment, CPRA).

Nationale Anwendungsebene:

Länder:

 

USA - United States of America

Status:

Published 2023-04-14 by Benjamin Kerger and Anne Barsuhn
Last change 2024-03-15 by Benjamin Kerger: Hints, Cybersecurity

ID:

#7v69


Inhalt des Regulatory Essentials

Legislation in force for this PCT
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Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation
CFR Title 32 – National Defense

- Contractors of the DEPARTMENT OF DEFENSE (DoD) are required to report cyber incidents.
- Voluntary DEFENSE INDUSTRIAL BASE (DIB) CYBER SECURITY (CS) program, purposed to to share cyber threat information and cybersecurity best practices. '

Responsible actors
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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)?

Authority
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Name of the authority for approval, registration, market surveillance and/or enforcement

Hints
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Specific recommendations, information or most common mistakes

Hints
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)

Specific recommendations, information or most common mistakes

Hints
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Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
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Product registration? Manufacturer registration? Importer / Representative registration? if required.

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
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Means each legally required approval process prior placing on the market, importation or putting into service

Is a factory inspection legally required
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Testing & Standards

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

Hints
Hier erhalten Sie zugehörige weiterführende Links

Specific recommendations, information or most common mistakes

Hints
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Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
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e. g. product label

Hints
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Specific recommendations, information or most common mistakes

Regulatory market access conditions for the actor(s)
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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)

Regulatory market access conditions for the actor(s)
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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
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Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
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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
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Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
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Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)
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Hints
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Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
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Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
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[Yes/No]

Hints
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Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
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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
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e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
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Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
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e .g. formal application

Is a factory inspection legally required
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Hints
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Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
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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
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Is in-country testing legally required?
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Acceptance of foreign test reports
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Hints
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Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
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e. g. product label

Regulatory e-labelling allowed?
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e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
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e. g. address of the manufacturer/importer, serial number

User instructions language(s)
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Regulated by the legal provisions

User instruction requirements and specific compliance notes
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Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Hints
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Specific recommendations, information or most common mistakes


Allgemeine Informationen

   
USA - United States of America

Code, Kontinent, Wirtschaftsraum

USA, North America

Wirtschaftsraum

Offizielle Amtssprache

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.

Normen Institut

American National Standards Institute - ANSI | https://ansi.org/

HS Codemitglied

Yes, since 1970

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