
USA FDA REGISTERED AGENT FOR A FOREIGN COMPANY
$1,500.00 PER YEAR

FDA LABELING REQUIREMENTS
GUDID REGISTRATION
$3,000.00 - $6,000.00 PER SKU
MAINTENANCE FEE VARIES BY COMPLEXITY, BUT STARTS AT $1,500.00

510K SUBMISSIONS
SIMPLE: $25,000.00
MODERATE: $49,500.00
COMPLEX: $69,500.00

LEGAL TRANSFER OF A 510K OR SALE FROM ONE HOLDER TO ANOTHER
$2,000.00

ESTIMATED TRIAL COSTS
SIMPLE: $5,000.00 PER SUBJECT
MODERATE: $7,500.00 PER SUBJECT
COMPLEX: $10,000.00 PER SUBJECT
