FDA Device and Drug Establishment Registration and Listing Requirements
Under the MDUFMA law, on an annual basis, contract sterilizers such as STERIS Applied Sterilization Technologies are required to register their facilities with the FDA and list the Customer’s devices and/or drugs that are processed in its facilities.
To request a product listing spreadsheet, please click here. The completed listing spreadsheet and any questions should be emailed to Device_Registration@steris.com.
The spreadsheet should be submitted if any of the following apply:
- You have changes to previously provided product information
- Or you have new products that STERIS AST is processing
To facilitate drug product listings by STERIS, please submit drug product information, including the drug name and NDC identifier OR the most recent drug listing, in .xml file format to Drug_Products@steris.com.
If you are not sure if STERIS AST has already listed your medical device with the FDA, you can check using the instructions posted here: Medical Device Listing FDA Website Guidance.
Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.