You’ve probably heard about the parks and museum closures that have taken place due to the government shutdown, but what about Bogobrush? Are we affected? The answer is “maybe.” Here’s how:
- -Toothbrushes are a “Class I Medical Device,” which means Bogobrush, the company, must register with the FDA each year to distribute toothbrushes to the public.
- -If a company registers on, or after October 1 of a given year, that company is registered for the remainder of that year, plus the upcoming year.
- -For Bogobrush to distribute product in December 2013, and also be registered for 2014, we need to register In October.
- -The government shutdown prevents any new registrations from occurring, which means we need the government to open back up soon, so we can get Bogobrushes to everyone.
- -The assembly facility must be an FDA certified factory.
- -We bristle and assemble packaging in the U.S. to guarantee the products are actually made in an FDA certified facility.
- -”Class I medical device” means it’s a common medical device, and is not introducing a new medical invention to the public. This allows Class I Medical Device Companies, like Bogobrush, to simply register their device with the FDA, rather than go through the rigorous testing process that complex, new invention medical devices must go through. If this class didn’t exist, all toothbrushes would be a lot more expensive to everyone.