973-531-6226

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

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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.

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