It looks like there may be a backdoor for some companies to avoid paying the costly Medical Device User Fees. FDA published guidance at the end of May outlining how business may qualify as a “small business” under the MDUFA terms, and pay the fees at a “substantially discounted” rate.
It gets even better. The guidance also notes that small business may also be able to receive a waiver for the first premarket approval application or a drastic reduction from $220,000 to $55,000. Or if you’re going down the 510(k) route, the fee is half the standard amount.
To qualify the guidance lays out these ground rules:
- Reported “gross receipts or sales” of no more then $100 million for the most recent tax year
- Both US and foreign businesses may qualify
- If you have any affiliates, you must add their gross receipts or sales to yours and the total must be no more than $100 million
- If gross receipts or sales are no more than $30 million (including the gross receipts or sales of all of your affiliates), you will also qualify for a waiver of the fee for your first premarket application
In order to receive the wavier for the PMA the company must prove gross receipts or sales are no more than $30 million. This must also take into account all the companies affiliates. And of course, one more condition, this must be the first premarket application by the company.
If you check out the guidance, and the table showing just how much of a reduction a small business can expect, it’s pretty impressive. Do you think this back door is fair? Or, should the fees be even across the board? Share your opinion with us.
Photo Credit: marc falardeau