What is the purpose of the acknowledgement of receipt letter?
• your report has arrived; • it has been entered into our database; and • your report’s accession number. An acknowledgement of receipt letter is not an approval of your product nor does it mean that your report is adequate. Q13) What is an accession number? A) Accession numbers are unique identifiers for reports in our database, and are provided in the CDRH acknowledgement letters. An accession number facilitates communication about specific reports because all parties can use the accession number to identify the document being discussed. Additionally, FDA imports personnel use accession numbers to confirm that a manufacturer has, at a minimum, complied with the reporting requirements for the product being imported. Q14) Does an accession number for my report mean that CDRH has approved my product? A) No. An accession number means that your report has been received by CDRH’s file room, and some information about the manufacturer and product were entered into our database. Q15) Where a
