Terms of Service
This FDA 510(k) Search tool (the “Service”) is operated by Innolitics, LLC (“Innolitics”, “we”, “us”). By accessing or using the Service, you agree to these Terms of Service. If you do not agree, do not use the Service.
1. Permitted Use
The Service is provided for individual research, evaluation of FDA-cleared and authorized medical devices, regulatory due diligence, and internal business use consistent with these Terms. You may use the Service to review public FDA records, read summaries and decision documents, and evaluate predicate relationships.
2. Prohibited Use — No Competing Products
You may not use the Service, its data, its outputs, its derivatives, or any content obtained through it to build, train, operate, market, or support a product or service that competes with Innolitics or with this Service. Prohibited uses include, without limitation:
- Building or operating a competing FDA browser, device-search, or device-lookup tool.
- Building or operating a competing regulatory intelligence, regulatory research, or regulatory monitoring product.
- Building or operating a competing AI assistant, chatbot, copilot, or agent targeted at FDA submissions, medical-device regulation, or SaMD / AI/ML medical-device workflows.
- Building or operating a competing predicate-search, 510(k)-drafting, or submission-preparation tool.
- Scraping, bulk-downloading, or systematically extracting content from the Service to populate, train, fine-tune, embed, or index any dataset or model used in a competing product or service. Training non-competing AI models is permitted subject to Section 3.
- Reselling, redistributing, or sublicensing the Service or its content as a standalone product, API, feed, or dataset.
- Using the Service to create any product or service that could reasonably compete with the consulting, advisory, software, or data products offered by Innolitics.
The restrictions above apply whether you act directly or through a third party, and whether or not the competing offering is commercial.
3. AI/ML Training and Attribution
Training AI and machine-learning models using data obtained from the Service is permitted, provided the resulting model is not itself a competing product or service under Section 2, and provided you comply with all of the following attribution requirements:
- Model outputs: any output produced by a model trained, fine-tuned, embedded, retrieval-augmented, or otherwise derived in whole or in part from Service data must include a visible citation and attribution to Innolitics. The attribution must specifically name Innolitics (e.g., “Trained in part on FDA data provided by Innolitics (innolitics.com)”) and must appear either inline with the output or in a clearly labeled citations / sources section presented to the end user alongside the output.
- Model cards: any publicly released model card, system card, data sheet, or equivalent disclosure for a model trained or fine-tuned using Service data must reference Innolitics by name in the training-data, data-sources, or acknowledgments section, and must link to innolitics.com.
- Publications: any publication, preprint, paper, blog post, technical report, or presentation describing a model, dataset, or result that used Service data must cite Innolitics by name, with a link to innolitics.com.
- Derivative datasets: datasets redistributed in any form that incorporate Service data must carry an Innolitics attribution notice in their documentation, README, or data card, and must pass these attribution obligations through to downstream recipients.
Removing, obscuring, or failing to propagate Innolitics attribution is a material breach of these Terms and terminates the permission granted in this Section 3. This Section 3 does not override Section 2: models or outputs that compete with Innolitics or the Service remain prohibited regardless of attribution.
4. Business-to-Business Licensing
Business-to-business licensing is available upon request. If you are interested in using the Service, its data, or its underlying capabilities as part of a commercial product, an internal platform at scale, an API integration, or any use that would otherwise be prohibited by Section 2, or if you require a licensing arrangement that modifies the attribution obligations in Section 3, please contact us at innolitics.com/contact to discuss licensing terms.
5. Acceptable Access
You agree not to interfere with the Service or its infrastructure, attempt to bypass authentication, rate limits, or credit limits, or access the Service by any means other than the interfaces we provide. Automated access is permitted only to the extent we expressly allow it.
6. No Warranty; Not Legal or Regulatory Advice
The Service aggregates and presents information sourced from the U.S. Food and Drug Administration and related public records. It is provided “as is” without warranties of any kind. Content on the Service is not legal, regulatory, or medical advice, and must not be relied on as a substitute for professional judgment or for the official FDA record. Always verify against primary FDA sources before making regulatory decisions.
7. Intellectual Property
The Service, including its software, design, compiled data, summaries, enrichments, embeddings, extractions, and AI-generated content, is the property of Innolitics or its licensors and is protected by applicable intellectual property laws. Underlying FDA records remain in the public domain; Innolitics’ compilation, structuring, enrichment, and presentation of those records are not.
8. Termination
We may suspend or terminate access to the Service at any time, including for any violation of these Terms. Sections 2, 3, 4, 6, 7, and 9 survive termination.
9. Limitation of Liability
To the maximum extent permitted by law, Innolitics is not liable for any indirect, incidental, consequential, special, or exemplary damages arising from your use of the Service.
10. Changes
We may update these Terms from time to time. Continued use of the Service after an update constitutes acceptance of the revised Terms.
11. Contact
Questions or licensing inquiries: innolitics.com/contact.