Research on defined product requirements and the use of standards in the United States. Each record identifies its scope, source and practical evidence questions.
Market scope
Federal first; state/local, workplace and procurement overlays separate.
The records below examine specific provisions and standards relationships. They do not combine different products or regulatory roles into one approval route.
Document the medical-device quality management system
21 CFR 820.10 · 820.10(a)
A covered manufacturer must document a quality management system meeting the applicable incorporated ISO 13485 requirements and the additional applicable requirements in Part 820. The regulatory document controls the US obligation: an ISO certificate alone does not establish compliance with the full FDA framework. Design, reporting and traceability provisions have their own conditions.
Scope, actions and official sources
Issuer
Food and Drug Administration
Status and context
In force for the stated scope
Edition or text examined
eCFR current, title updated 2026-10-16
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Manufacturers subject to Part 820 under section 820.1(a).
Scope and conditions
Scope and exemptions must be assessed under 820.1.,A quality-system obligation is not a marketing authorization.
Actions
Determine Part 820 applicability for the device and establishment.
Map the documented system to the incorporated edition and FDA additions.
Control changes to the system and its regulatory references.
Evidence identified by the source
Documented quality management system meeting the applicable requirements.
Materials for the research review
Device and establishment scope assessment.
Crosswalk separating FDA additions from certification scope.
For an imported finished product, the importer is responsible for issuing the certificate. For US manufacture, the manufacturer normally issues it; the current rule also assigns responsibility to a private labeler unless the manufacturer issues the certificate. First determine the underlying rule that makes certification necessary.
Scope, actions and official sources
Issuer
Consumer Product Safety Commission
Status and context
In force for the stated scope
Edition or text examined
eCFR current, title updated 2026-10-15
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Finished products that require a certificate under section 1110.5.
Scope and conditions
A product-specific rule may provide otherwise.,Products outside the certificate requirement are not brought within it by this section.
Actions
Identify the rule requiring a certificate.
Assign the correct certifying entity for the supply route.
Issue a certificate meeting Part 1110.
Evidence identified by the source
Finished-product certificate required by the applicable rule and Part 1110.
Materials for the research review
Importer/manufacturer/private-label roles.
Consistency between product identifiers, certificate and supporting assessment.
Clear the applicable authorization route before radio-device marketing
47 CFR 2.803 · 2.803(a)-(b), (d)
Marketing includes more than delivery of a finished device. The current rule addresses online listings combined with specified fulfilment activities and requires the appropriate authorization and technical, identification and labeling compliance. Certification, Supplier’s Declaration of Conformity and devices without a grant requirement follow different paths; limited advance-marketing exceptions are conditional.
Scope, actions and official sources
Issuer
Federal Communications Commission
Status and context
In force for the stated scope
Edition or text examined
eCFR current, title updated 2026-10-16
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Persons marketing radiofrequency devices within the rule definition.
Scope and conditions
Specific pre-authorization exceptions require all their stated conditions.,This record does not treat future online-display compliance dates as already due.
Actions
Classify the device authorization route.
Check authorization validity and the required product identification before marketing.
Use an advance-marketing exception only after documenting every condition.
Evidence identified by the source
Applicable authorization and required technical, labeling, identification and administrative compliance.
Materials for the research review
FCC ID or Supplier’s Declaration route matched to the actual model.
Review of marketplace activities and any exception relied upon.
Maintain a written food recall plan when preventive controls are required
21 CFR 117.139 · 117.139(a)-(b)
The written plan must assign responsibility and describe how the facility will notify direct consignees, communicate with the public when appropriate, verify recall effectiveness and dispose of affected food appropriately. The plan connects a preventive-control finding to an operational response rather than serving as a generic contact list.
Scope, actions and official sources
Issuer
Food and Drug Administration
Status and context
In force for the stated scope
Edition or text examined
eCFR current, title updated 2026-10-16
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Food with a hazard requiring a preventive control at a facility subject to the relevant Part 117 provisions.
Scope and conditions
Part 117 scope, exemptions and modified requirements require separate assessment.,The trigger is not every food product without a hazard analysis.
Actions
Identify the food and preventive-control trigger.
Assign responsible people and recall procedures.
Include effectiveness checks and safe disposition arrangements.
Evidence identified by the source
Written recall plan with the procedures and responsibilities specified in 117.139.
Materials for the research review
Consignee information and recall communication channels.
A practical check that recalled lots can be located.
Covered finished goods or their boxes or bundles must carry the required English identification, production month/year and TSCA Title VI compliance statement. Where individual goods are not labeled, the downstream party must retain and link the label information. Importers, distributors and retailers must preserve labels, and import timing is addressed separately in paragraph (f).
Scope, actions and official sources
Issuer
Environmental Protection Agency
Status and context
In force for the stated scope
Edition or text examined
eCFR current, title updated 2026-10-16
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Fabricators of finished goods containing regulated composite wood, and downstream importers, distributors and retailers.
Scope and conditions
The limited de minimis exception in paragraph (e) has conditions and exclusions.,Part 770 product definitions and other exemptions remain relevant.
Actions
Determine whether the wood and finished good are within Part 770.
Apply the required label and maintain product-to-label linkage.
Check labeling before US import and preserve it downstream.
Evidence identified by the source
Required finished-good label.
Retained label information and product linkage where individual labeling is not used.
Materials for the research review
Composite-wood supplier and product classification.
Any de minimis calculation and combination-use exception.
The supply chain must make a test summary available with the prescribed manufacturer, laboratory, report, battery, test-result and responsible-person information. It must identify the UN Manual revision and amendments used. This record concerns availability of the summary, not a requirement to attach it physically to every package.
Scope, actions and official sources
Issuer
Pipeline and Hazardous Materials Safety Administration
Status and context
In force for the stated scope
Edition or text examined
eCFR current, title updated 2026-10-15
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Manufacturers and subsequent distributors of covered lithium cells and batteries manufactured on or after 1 January 2008.
Scope and conditions
Button cells installed in equipment, including circuit boards, are excepted by this paragraph.,A test summary does not replace all transport packaging, mode or quantity rules.
Actions
Obtain a summary for the exact cell or battery model.
Check the elements listed in paragraph (a)(3).
Provide an accessible supply-chain method for making it available.
Evidence identified by the source
Test summary containing the elements specified in 173.185(a)(3).
Materials for the research review
Model-to-summary match and access arrangements.
Separate assessment of damaged, prototype or other special transport cases.
These records distinguish adoption, legal incorporation, designation and programme recognition. A standard’s use is assessed within the specific relationship recorded.
Standards relationship · UNITED-STATES-R01
ISO 13485:2016 is incorporated into the FDA device quality framework
21 CFR 820.7(b) · 820.7(b)
The regulation identifies ISO 13485:2016(E), including its edition and date, as incorporated for specified Part 820 sections. Its legal role comes from the US regulation. FDA-specific provisions still apply, and a commercial certification decision is distinct from an FDA determination.
Scope, actions and official sources
Issuer
Food and Drug Administration
Status and context
Verified relationship for the stated edition and scope
Edition or text examined
ISO 13485:2016(E), third edition, 2016-03-01
Relationship
Legal incorporation
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
The provisions of Part 820 for which FDA approves incorporation by reference.
Scope and conditions
This is edition-specific legal incorporation, not adoption of every later ISO revision.,Private standard text remains subject to separate access rights.
Actions
Use the edition named in 820.7.
Read the corresponding FDA provisions alongside the standard.
Record later-version claims separately from the legally incorporated edition.
Evidence identified by the source
Applicable incorporated requirements through the cited Part 820 provisions.
ASTM F963-23 supplies the incorporated US toy-safety requirements
16 CFR 1250.2 · 1250.2(a)-(b)
Part 1250 incorporates ASTM F963-23 for applicable toy provisions but expressly carves out identified content. The legal reference therefore has a defined boundary: neither the entire publisher document nor every toy-related provision is automatically part of this particular mandatory standard.
Scope, actions and official sources
Issuer
Consumer Product Safety Commission
Status and context
Verified relationship for the stated edition and scope
Edition or text examined
ASTM F963-23
Relationship
Legal incorporation
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Toys and applicable provisions within Part 1250.
Scope and conditions
Paragraph (b) excludes specified provisions from the incorporated mandatory standard.,Age, product and test applicability must be assessed independently.
Actions
Confirm the toy and applicable provisions.
Identify the paragraph (b) exclusions.
Coordinate the toy assessment with other applicable CPSC rules.
Evidence identified by the source
Compliance with the applicable incorporated provisions.
Materials for the research review
Correct ASTM edition and regulatory exclusions.
Separate testing and certificate obligations for the product.
US lithium transport rules refer to UN subsection 38.3
49 CFR 171.7 and 173.185 · 171.7(dd)(2); 173.185(a)(1)-(2)
Section 171.7 identifies the incorporated UN Manual editions; section 173.185 applies subsection 38.3 and includes rules for previously tested types. The applicable edition cannot be inferred from the newest UN publication alone. The type-test report and the later summary are different records.
Scope, actions and official sources
Issuer
Pipeline and Hazardous Materials Safety Administration
Status and context
Verified relationship for the stated edition and scope
Edition or text examined
UN Manual seventh revised edition (2019) and Amendment 1 (2021), with 173.185 legacy provisions
Relationship
Legal incorporation
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Lithium cell and battery types offered for transport under the cited US rule.
Scope and conditions
Specific exceptions and alternative conditions elsewhere in 173.185 need separate review.,This is US use of a UN reference, not a US-authored test standard.
Actions
Check the US incorporation entry.
Establish the edition applicable to the tested type.
Keep the underlying test record and summary roles distinct.
Evidence identified by the source
Record of successful type testing under 173.185(a)(2).
Materials for the research review
Type identity and permitted legacy route.
Current transport-mode and exception assessment.
Dates and application
Source Version
UN Manual seventh revised edition (2019) and Amendment 1 (2021), with 173.185 legacy provisions
UL 62368-1 appears on OSHA’s appropriate NRTL test-standard list
UL 62368-1 appears on OSHA’s appropriate NRTL test-standard list · UL 62368-1 list entry; 29 CFR 1910.7 framework
OSHA lists UL 62368-1 as an appropriate test standard for its NRTL programme. A valid programme claim also depends on the laboratory’s specific recognized scope, site and certification mark. The general list is not an edition-specific product certificate or a universal market-access rule.
Scope, actions and official sources
Issuer
Occupational Safety and Health Administration
Status and context
Verified relationship for the stated edition and scope
Edition or text examined
UL 62368-1; edition not specified by this list entry
Relationship
Programme use or recognition
Legal character
Recognised for the stated purpose
Source check
2026-10-20
Applies to
Product certification within the NRTL programme and an individual laboratory’s recognized standard and site scope.
Scope and conditions
The list does not prove that every NRTL is recognized for this standard.,It is not OSHA endorsement or approval of every ICT product.
Actions
Identify the individual NRTL.
Verify its standard and site scope.
Match the certification mark and product to the actual certification.
Evidence identified by the source
Programme conditions described by OSHA apply when NRTL certification is relied upon.
Materials for the research review
Laboratory scope, site and product listing.
Separate workplace approval requirements.
Dates and application
Source Version
UL 62368-1; edition not specified by this list entry
The linked official sources establish the provisions, document identities or relationships examined. NCQM supplies original English analysis. Where an official source is in another language, the English explanation is not an official translation. Source-check dates, effective dates and adopted editions are kept separate.
The research review materials help organize an assessment. They are distinguished from evidence expressly identified by the source. International standards remain subject to their publishers’ access and rights conditions.
