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  • Dataset id: fda_product_classification
  • Jurisdiction: US · FDA
  • Date field: none. A search that sets date_from or date_to skips this dataset and reports it as skipped.
  • Access: any API key.

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Filters

Send these under filters.fda_product_classification in a search request. A filter not listed here, or a value of the wrong type, is a 400.
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string
Exact product code (e.g., ‘DXN’, ‘QMO’).
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string
Keyword match on generic/non-branded device name (BM25 tokenized). This is the FDA classification name, not the marketed product name. Example: ‘infusion pump’.
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string
Exact device class. Values: ‘1’, ‘2’, ‘3’.
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string
Exact regulation number (e.g., ‘868.1750’).
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string
Exact 2-letter medical specialty code (e.g., ‘AN’ for Anesthesiology).Values: AN, CH, CV, DE, EN, GU, HE, HO, IM, MI, NE, OB, OP, OR, PA, PM, RA, SU, TX.
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string
Exact submission type ID. 1=510(k), 2=PMA, 3=Contact ODE, 4=510(k) Exempt, 6=HDE (Humanitarian Device Exemption), 7=Enforcement Discretion, 8=EUA (Emergency Use Authorization).Values: 1, 2, 3, 4, 6, 7, 8.

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Fields

Each result from this dataset has these in fields: definition, device_class, device_name, gmp_exempt_flag, implant_flag, life_sustain_support_flag, medical_specialty, medical_specialty_description, product_code, regulation_number, review_panel, submission_type_id, third_party_flag, url