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Regulatory ESSENTIAL
USA - Laser FDA

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

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Stakeholders:      Manufacturer, Importer     
Application: laser
Countries: Image for US USA - United States of America,  
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Status: Published 2023-03-27 by Torsten Sahm and Inken Green
Last change 2023-12-21 by Torsten Sahm: Legislation in force for this PCT, Laser general requirements
   
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Subject Areas of this Essential:


Laser general

Scope of this ESSENTIAL
This ESSENTIAL describes the legal obligations for manufacturers and the regulatory requirements for electronic product radiation as specified in the U.S. federal legislation.
The medical Lasers are not in scope of this ESSENTIAL'

Analysis of regulatory requirements

Legislation in force for this PCT
here you will get a image or chart

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)?

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)?

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Scope of legislation
21 CFR 1000.3

(j) Electronic product:
(1) Any manufactured or assembled product which, when in operation:
(i) Contains or acts as part of an electronic circuit and
(ii) Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(2) Any manufactured or assembled article that is intended for use as a component, part, or accessory of a product described in paragraph (j)(1) of this section and which, when in operation, emits (or in the absence of effective shielding or other controls would emit) such radiation.

(k) Electronic product radiation:
(1) Any ionizing or nonionizing electromagnetic or particulate radiation, or
(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

In general:
Any device which may emit laser light under any circumstances (normal-, service-, defect- operation).
'

Scope of legislation
here you will get a image or chart

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)

Hints
here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Registration at related authority required?
here you will get related hyperlink(s)

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
here you will get textual information

[Yes/No]

Hints
here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

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

Is the IECEE CB Scheme accepted by the authority/approval body?
here you will get textual information

"[Yes/ No / no information available] [Text] Information (website)"

Conformance document(s) to show compliance to the authority
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

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 a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

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

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 textual information

e .g. formal application

Is a factory inspection legally required
here you will get textual information

Hints
here you will get linked document(s)

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

Specific requirements for testing
here you will get related hyperlink(s)

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 textual information

Is in-country testing legally required?
here you will get textual information

Acceptance of foreign test reports
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

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

Required information on the product and/or packaging
here you will get related hyperlink(s)

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

Warnings, symbols
here you will get textual information

e. g. ANSI Z 535.4

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

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

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