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  2. Product Code Builder

    www.accessdata.fda.gov/scripts/ora/pcb/index.cfm?action=main.pcb

    This is the quickest way to find a Product Code. Enter a word from the product name or a keyword associated with the product name. For example, if you are coding swordfish you can enter 'sword' 'fish', or 'swordfish.'

  3. PCB API - Food and Drug Administration

    www.accessdata.fda.gov/scripts/ora/pcb/apidocs

    Welcome to the Product Code Builder (PCB) API Usage Documentation page. The documentation provides information regarding how the API retrieves the FDA product code information based upon the code portions selected for each of the five components (Industry, Class, Subclass, PIC, and Group) using the various REST Endpoints.

  4. Product Classification - Food and Drug Administration

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/pcdsimplesearch.cfm

    This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.

  5. CFR - Code of Federal Regulations Title 21 - Food and Drug...

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=170.3

    The information on this page is current as of Aug 30, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 170.3 Definitions. (a) Secretary means the Secretary of Health and Human Services.

  6. Product Classification - Food and Drug Administration

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=OMP

    The device is designed to provide a pre-set level of negative pressure to the wound bed. Target Area. For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Regulation Medical Specialty.

  7. Import Alert 98-04 - Food and Drug Administration

    www.accessdata.fda.gov/cms_ia/importalert_1136.html

    Note: The revision of this Import Alert (IA) dated 02/13/2023 updates the reason for alert, guidance section including agency contacts, charge code language, and product description. Changes to the import alert are bracketed by asterisks (***).

  8. Product Classification - Food and Drug Administration

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=IRT

    Product Classification. Powered heating pad. GMP Exempt? subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

  9. Product Classification - Food and Drug Administration

    www.accessdata.fda.gov/.../cfPCD/classification.cfm?start_search=1&ProductCode=PLS

    Product Classification. The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens.

  10. Food and Drug Administration

    www.accessdata.fda.gov/scripts/ora/pcb/apidocs/pcb-python.txt

    import json. import datetime. #create a signature and append it to the URL to avoid cached responses from server. signature = str(int(datetime.datetime.now().timestamp())) #set the url. url = 'https://www.accessdata.fda.gov/rest/pcbapi/v1/product/name/?signature='+signature.

  11. Radiation Emitting Electronic Product Codes

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm?PCD=RCJ

    Product Description: Veterinary X-Ray Systems Product Code: RCJ: Radiation Type: Ionizing Radiation Safety Report Type Required? Abbreviated Annual Reports Required? Yes Applicable Performance Standard(s) No standard applicable. General Radiological Health requirements apply. [1000-1005] - - Links on this page: Page Last Updated: 10/28/2024 ...