The process was updated on September 1 to simplify the EPRC submission process for manufacturers, the center noted. Manufacturers must submit variance applications in order to receive permission to vary from performance standards.
The changes include updates to variance-related forms and creating an optional but encouraged cover sheet to provide additional information. The CDRH also no longer requires applicants to send a separate application to the Dockets Management Staff.
The CDRH asks applicants to ensure each submission contains individual PDFs for the cover sheet, application, and supporting materials. To submit a variance application, applications can email their documents to RadHealthCustomerService@fda.hhs.gov.
Upon receipt, the Document Control Center will forward applications to the Dockets Management Staff. The Dockets Management Staff will then issue an acknowledgement letter and Docket number.
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