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How much does a PMA cost?

Part of the cost is in the form of a user fee from the FDA, with the standard fee for PMA set at nearly $235,000, compared to $4,690 for 510(k). PMA requires extensive data from laboratory and clinical studies, which are not required under the more lenient 510(k) process.

How long does it take to approve a PMA?

While preparing a PMA application is generally significantly more intensive than a 510(k) app or self-registration, it's surprisingly not much longer of a wait post-submission. According to a report from the agency, the average PMA application is approved 243 days post-submission.

How are FDA user fees paid?

Mailing in a Paper Check Funds must be in U.S. currency. Check made payable to Food and Drug Administration (must be in U.S. dollars and drawn on a U.S. Bank) Write the FDA post office box number ( PO Box 70961) on the check. Write the Payment Identification Number (PIN) on your check.

What is FDA user fee?

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

What is a FDA cover sheet?

The cover sheet creation process gathers the minimum amount of information necessary to determine whether a fee is required, to determine the amount of the fee, and to allow FDA to track payments.

medical device user fee cover sheet

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How much is a PMA?

Rare and Costly Process Part of the cost is in the form of a user fee from the FDA, with the standard fee for PMA set at nearly $235,000, compared to $4,690 for 510(k). PMA requires extensive data from laboratory and clinical studies, which are not required under the more lenient 510(k) process.

Is PMA only for Class 3?

PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices. Device product classifications can be found by searching the Product Classification Database.

What is Mdufa IV?

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

How much does it cost to get a medical device FDA approved?

FDA Costs and Consulting Service Fees. How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

Do you have to pay for FDA approval?

Currently, the fees drug companies pay for the FDA to review new drugs run about $2 million each for applications that involve clinical trials. The fee doesn't guarantee that the FDA will approve the drug.

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