The objectives of this guidance is to reengineer and automate the FDA's application system for License to Operate (LTO) through online platforms.
It also aims to update the documentary and technical requirements for LTO applications and inspections of FDA-covered establishments.
The below-listed establishments, whether public or private, shall be covered by this Order:
1. Manufacturers, including Packers/Repackers; 2. Refurbishers of medical devices; 3. Traders; 4. Distributors as Importers, Exporters, and/or Wholesalers; 5. Drug outlets, such as drugstores, pharmacies (community, or institutional); or boticas, and retail outlets for non-prescription drugs (RONPDs); 6. Retailers of Medical Devices 7. Clinical Research Organizations (CROs) and Sponsors
The validity of the Initial LTO is 5 years and the Renewal is for 10 years. The Corresponding fees and other charges for the application of LTO is governed by FDA existing issuances.
Click this LINK to know more about the requirements for applying for LTO.
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