Silver Spring, MD, September 2017. Attention medical device manufacturers on the fence for a 510(k) submission date: On August 21, 2017, President Donald J. Trump quietly signed into law the FDA User Fee Reauthorisation Bill. Not a big deal, you say? Well, for starters, if you submit your 510(k) on September 29 (and The CRO Group recommends a few days earlier just in case there’s a hurricane or other reason for it not being received on time,) the fee is $4,690. Submitting that 510(k) so it’s received on 1 October? Now the fee is $10,566. That’s correct – a 125% increase! The increase is a tad easier to take if you’re filing and you meet the SBD (Small Business Decision) fee. Then the 510(k) submission fee increases from $2,345 to $2,642. Thinking this is another Fake News site? If you don’t believe us, check out this Federal Register page.
The FDA User Fee Reauthorisation Bill of 2017, commonly referred to as FDARA, allows FDA to collect fees for drug and device reviews and approvals and establishment registrations through 2022. Health and Human Services Secretary Tom Price said “by signing the FDA Reauthorization Act of 2017 into law, President Trump is ensuring that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs, to generic drugs, biosimilars, and medical devices.” The Senate passed the bill 94-1, with only Vermont Senator Bernie Sanders voting against, saying the Bill did ‘nothing to lower drug prices and is a giveaway to the pharmaceutical industry,” according to comments from his spokesman when asked about why he voted against.
If you have a 510(k) that is ‘almost ready’, or not quite there yet – relax – The CRO Group is here to assist. From our new office in San Jose, or the Boston HQ, we’re here to help. We also offer contract regulatory associates for a day, a week, or even longer to help ensure that that 510(k) completes swiftly so you don’t get hit with the 125% increase. And, if you’re a small startup with little revenue to speak of, we can walk you through the SBD process so there’s no 510(k) sticker shock. All in all, it makes for a pleasant experience. To get in touch with one of our pros, click here, or you can