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Regulatory compliance

Checks against industry and government rules to flag violations before anything goes live

‍

Best practices

Channel-specific guidance to reduce rejections and lift engagement

Creative compliance

Claim wording, imagery, targeting and audience suitability

Platform & channel policies

Stay aligned with evolving ad and content policies

Accessibility 
& transparency

Plain language, inclusivity, and readability checks so content is clear, accessible, and trustworthy

Brand consistency

Upload your internal rules and style guides to enforce voice, terminology, and visual identity across every asset

Regulatory compliance

Checks against industry and government rules to flag violations before anything goes live

Best practices

Channel-specific guidance to reduce rejections and lift engagement

Creative compliance

Claim wording, imagery, targeting and audience suitability

Platforma and channel policies

Stay aligned with evolving ad and content policies

Accessibility & transparency

Plain language, inclusivity, and readability checks so content is clear, accessible, and trustworthy

Brand consistency

Upload your internal rules and style guides to enforce voice, terminology, and visual identity across every asset

Find checks* that fit your needs

*Check is a set of rules grouped under one topic that checks whether content follows the requirements,
guidelines, or best practices related to that topic.

Food & Drug Products – Product Definitions & Classification Standards (Federal Food, Drug, and Cosmetic Act)
FDA
Establishes legal definitions and classification standards for food, drugs, devices, cosmetics, and dietary supplements under federal law.
December 5, 2025
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Food & Drug Products – Product Definitions & Classification Standards (Federal Food, Drug, and Cosmetic Act)
FDA
US
December 5, 2025
What it checks
•
Product Classification – Defines categories for food (including dietary supplements), drugs (prescription and OTC), medical devices, and cosmetics with specific criteria for each classification.
•
Device Definition – Specifies medical devices as instruments for diagnosis, treatment, or prevention that do not achieve primary purposes through chemical action or metabolism in the body.
•
Drug vs. Supplement Distinction – Establishes that products making structure/function claims under Section 343(r) are not classified as drugs solely based on truthful, non-misleading statements about nutritional support.
Where it applies
Industries:
Pharma & Healthcare, Food & Beverage, Consumer Goods (CPG)
Content types:
Packaging & Labeling, Product Descriptions, Legal & Regulatory
Channels / platforms:
Packaging, Retail, Ecommerce, Web
Tobacco Product Labeling – Warning Requirements & Health Claims (Tobacco Control Act)
FDA
Regulates tobacco product warning labels, health claim restrictions, and required disclosures per FDA tobacco control requirements.
December 5, 2025
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Tobacco Product Labeling – Warning Requirements & Health Claims (Tobacco Control Act)
FDA
US
December 5, 2025
What it checks
•
Warning Labels – Requires specific health warning statements on all tobacco product packages and advertisements, including placement, size, and format specifications (e.g., minimum 30% of package display area).
•
Required Disclosures – Mandates disclosure of nicotine content, addictiveness warnings, and health consequence statements in all promotional materials and packaging (e.g., "WARNING: This product contains nicotine. Nicotine is an addictive chemical.").
•
Health Claims – Prohibits false or misleading health claims about tobacco products, including modified risk claims without FDA authorization (e.g., "light," "low tar," "reduced risk").
Where it applies
Industries:
Alcohol & Tobacco, Pharma & Healthcare
Content types:
Packaging & Labeling, Ads & Social Media, Print Materials, Retail & In-Store, Product Descriptions
Channels / platforms:
Packaging, Retail, Print, Web, OOH
Medical Device Premarket Approval – PMA Application & Reporting Requirements
FDA
Regulates FDA premarket approval process for medical devices, including application requirements, review procedures, and post-approval obligations.
December 5, 2025
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Medical Device Premarket Approval – PMA Application & Reporting Requirements
FDA
US
December 5, 2025
What it checks
•
PMA Application Requirements – Sponsors must submit complete applications including device description, proposed labeling, manufacturing information, and clinical data demonstrating safety and effectiveness for intended use.
•
Post-Approval Monitoring – Requires submission of periodic reports, device recall notifications within 30 working days, and final investigation reports within 6 months of study completion or termination.
•
Investigation Reporting Obligations – Sponsors must report unanticipated adverse device effects within 10 working days, submit progress reports at 6-month intervals, and notify FDA of IRB approval withdrawals within 5 working days.
Where it applies
Industries:
Pharma & Healthcare
Content types:
Packaging & Labeling, Product Descriptions, Legal & Regulatory
Channels / platforms:
Web, Packaging, Retail
Biological Products Licensing – FDA Application & Manufacturing Standards
FDA
Regulates FDA licensing procedures, manufacturing standards, and distribution requirements for biological products including vaccines and blood products.
December 5, 2025
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Biological Products Licensing – FDA Application & Manufacturing Standards
FDA
US
December 5, 2025
What it checks
•
Licensing Requirements – Manufacturers must submit detailed applications including product characterization, manufacturing processes, and facility information before marketing biological products.
•
Post-Approval Changes – Establishes tiered supplement requirements (prior approval, changes being effected, annual reports) based on the potential impact of manufacturing or labeling modifications.
•
Manufacturing Standards – Requires compliance with cGMP, validation protocols, facility inspections, and notification of manufacturing disruptions that could lead to product shortages.
Where it applies
Industries:
Pharma & Healthcare
Content types:
Packaging & Labeling, Product Descriptions, Legal & Regulatory
Channels / platforms:
Packaging, Retail, Ecommerce, Web
Medical Device Labeling – Identification & Disclosure Standards (21 CFR Part 801)
FDA
Establishes comprehensive labeling requirements for medical devices, including manufacturer identification, unique device identifiers, and warning statements.
December 5, 2025
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Close
Medical Device Labeling – Identification & Disclosure Standards (21 CFR Part 801)
FDA
US
December 5, 2025
What it checks
•
Manufacturer Information – Requires conspicuous display of manufacturer, packer, or distributor name and place of business on device labels, with specific corporate name format requirements and relationship disclosure for non-manufacturers.
•
Adequate Directions & Warnings – Requires clear directions for use, prohibits misleading statements, and mandates specific warning labels for certain device categories including prescription devices, latex-containing products, and tampon toxic shock syndrome warnings.
•
Unique Device Identifier (UDI) – Mandates automatic identification and data capture technology on device labels, with specific requirements for direct marking of reusable devices and provisions for exceptions through formal request process.
Where it applies
Industries:
Pharma & Healthcare
Content types:
Packaging & Labeling, Product Descriptions, Legal & Regulatory
Channels / platforms:
Retail, Packaging, Ecommerce, Web
Investigational New Drugs – Clinical Trial Requirements & Safety Reporting (IND Application Requirements)
FDA
Regulates investigational new drug applications, clinical trial protocols, safety reporting obligations, and sponsor-investigator responsibilities.
December 5, 2025
Learn more
Close
Investigational New Drugs – Clinical Trial Requirements & Safety Reporting (IND Application Requirements)
FDA
US
December 5, 2025
What it checks
•
IND Application – Requires sponsors to submit investigational new drug applications including protocols, investigator qualifications, chemistry data, and pharmacology information before initiating clinical trials.
•
Sponsor & Investigator Duties – Establishes responsibilities for trial monitoring, informed consent, IRB approval, record retention, and compliance with FDA regulations throughout all investigation phases.
•
Safety Reporting – Mandates expedited reporting of serious adverse events within 15 days, annual safety reports, and protocol amendments when new safety information emerges during clinical investigations.
Where it applies
Industries:
Pharma & Healthcare
Content types:
Legal & Regulatory, Packaging & Labeling, Product Descriptions
Channels / platforms:
Packaging, Web, Print

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auto-updating Inspectors
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Have questions about our services?
Explore our detailed FAQ section
for in-depth answers and insights
How does GetGenAI stay up to date with regulations?
GetGenAI connects directly to regulatory databases and trusted sources through APIs, so our Inspectors update in real time as laws, advertising codes, or platform policies change — no manual tracking or revalidation needed.
Can I add my own rules or brand guidelines?
Yes. You can upload internal rules — like brand tone, claim wording, or style guides — and GetGenAI will turn them into private Checks for your team.
What do Check results look like?
You’ll see what’s wrong or risky, why it matters, and how to fix it — often with a one-click option to apply the change automatically.
What are GetGenAI Checks?
Checks are smart rule sets built for specific needs — from industry regulations to creative best practices and brand voice. Each one reviews your content through a focused lens, like “FDA rules for health ads” or “tone and readability for SEO.”
Can I run multiple Checks at once?
Yes. Most teams combine several — for example, Regulatory + Creative + Brand Consistency — to cover all angles in one quick review.
How do I choose which Checks to use?
You can select Checks based on your industry, content type, and region, but we’ll also help you choose the right mix during your demo — tailoring them to your brand, workflows, and compliance needs.
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