The Challenge
Regulatory submissions for medical devices and pharmaceuticals demand exhaustive evidence packages. Teams must search FDA drug records, pull 510(k) clearance documents, identify predicate devices, verify substantial equivalence claims against clinical data, and then map all of this against peer-reviewed literature—a process that routinely takes months when done manually.
- Locating and comparing 510(k) summaries and predicate device specifications across disparate FDA systems is time-consuming and error-prone
- Clinical trial evidence must be independently sourced and validated against published outcomes
- Substantial equivalence arguments require rigorous cross-referencing that manual workflows struggle to scale
- Development teams face mounting pressure to reduce submission cycles while maintaining evidentiary rigor
The Autohive Solution
With the Scite integration on Autohive, product development and regulatory affairs teams can automate the gathering, comparison, and synthesis of all evidence required for a regulatory submission—from FDA databases to peer-reviewed journals.
510(k) and Predicate Device Research
Agents retrieve full 510(k) summary documents directly from FDA records and automatically compare predicate device specifications, flagging similarities and differences relevant to your substantial equivalence argument.
Simultaneous Clinical and Literature Evidence
While querying FDA drug approval records and clinical trial databases, agents simultaneously pull peer-reviewed studies on comparable treatments or devices—building a comprehensive evidence package without the manual back-and-forth.
Regulatory Dossier Assembly
Agents compile and structure findings into submission-ready formats, including cited clinical data, device comparison tables, and safety literature summaries, dramatically reducing the time between evidence gathering and dossier completion.
Benefits
- Faster submissions - Reduce months of manual evidence gathering to days with automated retrieval
- Higher quality dossiers - Ensure comprehensive coverage of FDA records and peer-reviewed literature
- Reduced rework - Catch gaps in your evidence package before submission, not after reviewer feedback
- Stronger equivalence arguments - Build predicate comparisons backed by published clinical data
- Competitive intelligence - Monitor competitor clearances and drug approvals as part of your research workflow
How It Works
- Sign up at Autohive - Create your workspace and connect the Scite integration
- Define your submission scope - Specify the device or drug category, target indication, and regulatory pathway
- Run automated search - Agents query 510(k) databases, FDA drug records, clinical trial registries, and scientific literature simultaneously
- Review synthesized evidence - Receive structured comparisons of predicate devices and linked clinical evidence with citation context
- Compile your dossier - Use agent-generated summaries and citation reports as the foundation for your regulatory submission package
Getting Started
- Sign up at app.autohive.com
- Connect the Scite integration from the marketplace
- Configure your regulatory research agent with the target device or drug and submission pathway
- Deploy and receive your first automated evidence synthesis report
Learn more about the Scite integration on the Autohive marketplace.
