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Commentary: Getting the Government in Bed: How to Regulate

These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicon and provide electrical stimulation to the pelvic floor. Import Systems, information regarding the electronic import systems FDA utilizes to review and validate entry data and information. Experimental: ApexM Device, inControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence (10).

But the tech started out as an anti-nausea prescription for chemotherapy treatments, according to CMO Mark Goldstone, and got cleared for more general nausea and motion sickness indications later. The poor publicists had quite a job. How to start importing FDA regulated products.

Making things even more complicated, the tech's original clearances date back to 1999, and might even go back further. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically.