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Remove a registrations' association with a listing number.Associate other registrations with a listing number.Transfer Ownership of Devices or Facilities: Record an ownership transfer with the FDA, along with associated new owner information.Ĭreate Listings for Medical Devices: List your medical devices with CDRH.ĭownload Your Listing Information: Download Listing and Proprietary Name information through Excel files that may be saved and searched locally.Ĭhange, Deactivate, or Reactivate Listings: Modify your active medical device listings: You can reassign the official correspondent for one or as many facilities as necessary at the same time.
WINJECT 2016 REGISTRATION
View Your Registration and Listing Information: See all of your registrations and listings, both active and inactive, and view all recorded data associated with each of them.Ĭhange the Official Correspondent for a Facility: View all of your facility registrations along with the assigned official correspondents. Only registrations that are "Pending" assignment of a registration number can be cancelled. Edit the address or phone number for a facility.Ĭancel, Deactivate, or Reactivate a Facility Registration: Change the status of a device facility by deactivating or reactivating a registration.
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WINJECT 2016 UPDATE
Register a New Medical Device Facility: Use this option to create a registration for a new facility.Ĭhange Registration Information for a Facility: Update any registration information that has changed:
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Registration if you have not been assigned a Registration Number. Once you have logged in to DRLM, the Main Menu provides several options.Īnnual Registration: Use this option to complete theĪnnual device re-registration process. Select "Edit Account Profile" under Account Management in OAA. Note: To add your email address to your personal profile, please That an email address is both valid and associated to your account. Listing Module option from the OAA Main Menu screen, the system will validate Therefore, when you select the Device Registration and Getting Started - Logging into DRLM from OAA Annual Registration (Review of Device Registration Information).Change the Official Correspondent for a Facility.Add/Replace Proprietary Names or Importers to Listings.Change, Deactivate, or Reactivate Listings.Cancel, Deactivate, or Reactivate a Facility Registration.View Your Registration and Listing Information.Transfer Ownership of a Facility (Report Purchase).Change Registration Information for a Facility.Device Registration and Listing Module (DRLM): Step-by-Step Instructions