Establishment Registration and Medical Device Listing Files

This data package contains datasets on medical device establishment including foreign firms that manufacture medical devices, registered and non-registered importers with the Food and Drug Administration (FDA) listed by manufacturers, detailed list of the types of device establishments that are required to register at FDA and pay the fees. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo). This data package allows access to all related data.

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1. Medical Device Establishment Contact Addresses

This dataset showcases the establishment and listing provided by the FDA (Food and Drug Administration) with the location of medical device establishments and a list of devices manufactured at those establishments.

2. Medical Device Establishment Official Correspondent

Medical Device Establishment Official Correspondent dataset contains Medical Device Establishment Registration Official Correspondent Information. Most establishments that are required to register with the Food and Drug Administration (FDA) are also required to list the devices that are made there and the activities that are performed on those devices.

3. Medical Device Establishment Owner Operator

The U.S. Food and Drug Administration (FDA) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. The operators of such establishments are found in this dataset.

4. Medical Device Establishment Types

Medical Device Listing Establishment Types dataset contains the description of each Establishment Type ID. For combination products, identify the type of the combination (i.e., drug/device, etc.)

5. Medical Device Establishment US Agent

This dataset contains the Medical Device Establishment US Agent Information. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

6. Medical Device Listing Establishment Types

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA (Food and Drug Administration). All establishment registrations must be submitted electronically unless a waiver has been granted by FDA.

7. Medical Device Listing Product Code

This dataset contains Medical Device Listing Product Code information. Classification product codes are a method of internally classifying and tracking medical devices. CDRH and a subset of CBER regulated medical device product codes consist of a 3 letter combination which associates a device’s type with a product classification designated for the application. The information associated with these devices, such as names and attributes, are assigned by CDRH to support their regulation.

8. Medical Device Listing Proprietary Name

This dataset shows establishments that are required to register with the Food and Drug Administration (FDA) which are also required to list the devices that are made and the activities that are performed on those devices.

9. Medical Device Manufacturers Identified by Importers

This dataset shows foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products that emit radiation into the U.S., the product must meet FDA regulatory requirements. Food and Drug Administration (FDA) does not recognize regulatory approvals from other countries.

10. Medical Device Non-Registered Importers Identified by Manufacturers

This dataset shows establishments that are required to register with the Food and Drug Administration (FDA) that are also required to list the devices that are made there and the activities that are performed on those devices.

11. Medical Device Registered Importers Identified by Manufacturers

This dataset contains details of Medical Device Importers. Establishments that are required to register with the Food and Drug Administration (FDA) are also required to list the devices that are made there and the activities that are performed on those devices.

12. Medical Device Registration Listing

This dataset shows owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the Food and Drug Administration (FDA).

13. Medical Device Registration

Detailed list of the types of device establishments that are required to register and pay the fee can be found in this dataset. This dataset also contains Medical Device Establishment Registration Information including registration keys and full addresses of establishments.

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John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.