Thanksgiving night I was standing outside in the cold in a line that wrapped halfway around Target. My motivation for this spontaneous Black Friday door-buster shopping was peer pressure, but I was also excited to take advantage of the great prices. Even though I wasn't in the market for a new 50" HD TV for only $350, I still found good deals on some gloves and a new GPS. I took advantage of the deals and steals of the holidays. A good sale is just too hard to pass up.
The FDA has a few "deals and steals" of its own, thanks to the 2002 MDUFMA. Did you know that any 510(k) you file for pediatric use is completely free? It doesn't have to be holiday season to cash in this deal, the FDA has permitted anyone whose device is solely for kids to get a free pass. Also, any 510(k)s that are reviewed by a third party are exempt from a user fee. The third party may charge a review fee, however the fee is generally regarded as less expensive than the user fee. Additionally, it can be quicker to get your product cleared via third party review.
The most widely known "deals" that the FDA has are the Small Business discounts, for companies who have <$30 million in gross receipts. If your business qualifies as a small business, you'll be able to enjoy a 50% off discount for 510(k)'s (a savings of $2,480). In an even bigger deal, small businesses can submit their first PMA absolutely free (a savings of $62,000).
Consider this your Black Friday ad for discounts at the FDA. I only mentioned the door-buster specials, but there are other "sales" out there, if you shop around the FDA's MDUFMA website. Make sure to take advantage of the offers that are available.
- Sherri