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
FOR A SIMPLE TRIAL OF 20 SUBJECTS, THE ESTIMATED COST WOULD BE AROUND $100,000.00 INCLUSIVE OF ALL FEES. 
 
MOST CLASS I AND II MEDICAL DEVICES FALL INTO THIS CATEGORY, BUT THE FINAL FEE TOTAL DEPENDS ON THE COMPLEXITY OF THE DEVICE.

© 2020 by  NST Consultants Inc. 

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