Yes, the FDA is authorized to charge a fee of up to $175 per certificate. CDRH charges $175 for the first certificate and $85 for each additional certificate issued from the same application with the same list of products.
Each certificate cannot exceed a total of 25 pages (including the certificate, manufacturer page and product attachment pages). However, you may request as many copies as needed.
If a certificate exceeds 25 pages (including the certificate, manufacturer page, and product attachment pages), you will need to condense the information on the product attachment pages or split the request into two or more applications.
Example: If a certificate has 9 pages and you want 20 certificates, your total application includes 180 pages. Since the 25-page limit was exceeded eight times, you would be charged $175 x 8 for eight certificates and the remaining 12 certificates would be $85 each. Under this example you would be billed ($175 x 8 certificates) $1,400 + $1,020 for subsequent originals; the total bill for the entire request would be $2,420.
