Definitive reference for the regulatory bodies, procurement frameworks, and incentive programs that show up in cross-border US market entry. Each entry carries precise citations and links to the relevant pillar work.
Federal Risk and Authorization Management Program. Standardised approach for assessing, authorising, and continuously monitoring cloud products for US federal government use. Three baselines (Low, Moderate, High), Rev 5 from May 2023.
Read the entry →Cybersecurity Maturity Model Certification. DOD requirement for contractors handling Federal Contract Information or Controlled Unclassified Information. CMMC 2.0 has three levels finalised October 2024.
Read the entry →Federal Acquisition Regulation, codified at 48 CFR Chapter 1. Uniform policies and procedures for acquisition of supplies and services by US federal executive agencies. Issued jointly by DOD, GSA, and NASA.
Read the entry →Defense Federal Acquisition Regulation Supplement, codified at 48 CFR Chapter 2. DOD-specific supplement to FAR. Adds defense-mission-specific cybersecurity, domestic-source preferences, and Berry Amendment provisions.
Read the entry →North American Industry Classification System. Six-digit code identifying business industries. Required field on SAM.gov entity registration and federal RFP responses. Sets size standards for small-business eligibility.
Read the entry →General Services Administration Multiple Award Schedule. Long-term governmentwide contract providing federal/state/local agencies streamlined access to commercial products, services, and solutions at pre-negotiated terms.
Read the entry →System for Award Management. US federal entity registration database. Mandatory for any entity seeking federal contracts above the micro-purchase threshold. Includes UEI, CAGE/NCAGE, NAICS, FAR/DFARS reps and certs.
Read the entry →International Traffic in Arms Regulations, 22 CFR Parts 120-130. Administered by US State Department DDTC. Controls export and temporary import of defense articles and services on the US Munitions List.
Read the entry →Export Administration Regulations, 15 CFR Parts 730-774. Administered by US Department of Commerce BIS. Controls exports, re-exports, and in-country transfers of dual-use items via the Commerce Control List and ECCNs.
Read the entry →EU Medical Device Regulation replacing the Medical Device Directive. Full application 26 May 2021. Stricter clinical evidence, mandatory Notified Body involvement for higher classes, UDI, EUDAMED, PRRC. Does not equal FDA clearance.
Read the entry →Premarket Notification under Section 510(k) of the FD&C Act. 21 CFR Part 807 Subpart E. Most common FDA medical device pathway. Demonstrates substantial equivalence to a legally marketed predicate device.
Read the entry →Quality System Regulation. Current Good Manufacturing Practice for finished medical devices. Being harmonised with ISO 13485:2016 under QMSR, effective 2 February 2026.
Read the entry →FDA CDRH framework for pre-submission interactions. Pre-Sub, Submission Issue Request, Study Risk Determination, Informational and Agreement Meetings. Voluntary but recommended for novel devices and unclear pathways.
Read the entry →Production Part Approval Process. AIAG standard, currently Fourth Edition. Five submission levels with 18 elements. Required by Detroit Three (Ford, GM, Stellantis NA) and most global OEMs. European VDA 2 not directly substitutable.
Read the entry →Advanced Product Quality Planning. AIAG framework for automotive product development. Five phases with gate reviews, DFMEA, PFMEA, control plans, MSA, SPC. Required by IATF 16949 and customer-specific requirements.
Read the entry →International Automotive Task Force quality management standard. IATF 16949:2016 built on ISO 9001:2015. Required by IATF OEMs (BMW, Daimler, FCA/Stellantis, Ford, GM, JLR, Renault, VW). CSRs differ by OEM.
Read the entry →United States-Mexico-Canada Agreement rules-of-origin requirement. 75% RVC for passenger vehicles and light trucks (phased from 66%), 70% for heavy trucks. Plus 40-45% Labor Value Content at 16 USD/hour and 70% steel/aluminium rule.
Read the entry →Inflation Reduction Act 2022 Clean Vehicle Credit. Up to $7,500 federal tax credit for qualified clean vehicles. Critical-minerals requirement and battery-components requirement, phased 2024 through 2029. Foreign Entity of Concern restrictions.
Read the entry →Cornerstone guide for Mittelstand and DAX-listed operators. References every regulatory framework in this glossary in operator-context.
Read the guide →SAM.gov registration walkthrough, NAICS code mapping, GSA Schedule pathways, FAR Part 9 responsibility determination.
Read the handbook →Detailed walk through FedRAMP Rev 5, CMMC 2.0 levels, NIST SP 800-171/53, IL2-IL6, ITAR/EAR architecture, FOCI mitigation.
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