This bill significantly revises the small business waiver program for medical device establishment registration fees under the Federal Food, Drug, and Cosmetic Act. It redefines a small business as an entity employing fewer than 20 full-time equivalent employees, including affiliates, and mandates that the Secretary of Health and Human Services grant a waiver to eligible establishments, prohibiting consideration of prior payment history and requiring application of Small Business Administration standards. To qualify, establishments must submit proof of their size at least 60 days before the fee is due. The waiver provides 100 percent coverage for the first three years and 50 percent coverage for the subsequent two years, after which eligibility expires, and foreign companies are explicitly excluded from applying for these waivers. Furthermore, the bill imposes a substantially higher annual registration fee on foreign-owned or operated establishments, requiring them to pay eight times the standard fee, with these amendments taking effect 90 days after enactment.