Meridian Trace — Medical Device Registrations vs OpenFDA Regulatory Metadata

Meridian Trace — Medical Device Registrations tools

No tool names declared yet. Check the project README from the listing page.

OpenFDA Regulatory Metadata tools 7

• search_drug_labelSearch openFDA drug labels (SPL) for a term.
• lookup_drugsfda_applicationFetch Drugs@FDA application metadata for an NDA/BLA/ANDA number.
• resolve_drug_to_applicationResolve a brand or generic drug name to its NDA/BLA application number(s). Bridges drug-name-only sources (registry inventories, product lists) to FDA regulatory metadata. Searches the brand and generic name fields directly rather than label prose, so another product merely *mentioning* this drug does not produce a false match.
• screen_for_rwe_signalsEXPERIMENTAL. Sweep drug labels for registry / real-world-evidence signals. Searches the label corpus for terms suggesting registry, natural-history or other real-world evidence, then aggregates hits by application number with snippets showing where each term matched. **This tool is unvalidated and has a known false-positive problem.** It has no ground-truth oracle, and below the strongest hits the results are dominated by applications whose labels use "registry" in an unrelated sense. Its output is a candidate list for human review — not a finding, and not a count you should report.
• lookup_device_submissionLook up a CDRH device submission by its number. Handles all four device pathways: 510(k) K-numbers ("K203571"), De Novo grants ("DEN160026" — stored in the 510(k) endpoint, not a separate one), PMA P-numbers ("P230044"), and HDE H-numbers. Supplement suffixes ("P230044/S001") are stripped before lookup.
• classify_device_product_codeResolve a CDRH product code to its device class and medical specialty.
• validate_device_applicationValidate a device number and derive class, specialty and category in one call. Chains lookup_device_submission -> classify_device_product_code, which is the full three-hop resolution: number -> product_code -> classification.