Small Biz Burden

Medical device fees

Oregon seamstress and mother Denelle Philemon makes reusable cloth menstrual pads. Her company, MotherMoonPads, takes pride in "making things that will last" with high-quality, natural materials. But her business almost didn't survive 2014, after the U.S. Food and Drug Administration (FDA) announced it would step up enforcement of regulations that treat reusable pads as "medical devices."

The pads, which are simply pieces of sewn-together cloth worn in women's underwear, have officially been classified as medical devices since 1996. As a result, the FDA can force pad manufacturers to register and pay an annual fee. For 2015, it was $3,646-more than $1,000 higher than for 2013. The FDA's cut will rise again in 2016, to $3,872.

"I need to make the decision whether to…give up on this portion of my dream and transition into selling other products," Philemon posted on MotherMoonPads' Facebook page in December, with 2015's deadline looming and funds running low. Ultimately, she pushed enough product to make the money and register. But Philemon's case illustrates the burden such regulatory fees place on small business owners-and customers. This year, "there will be a slight increase in pad prices to help absorb the yearly FDA registration fee," notes the MotherMoonPads sales page.

Asked one mommyblogger, "Are…cloth diapers therefore also medical devices? And what about cloth breast pads that protect against leakage during lactation?…Where exactly does the regulation end?"