December 07, 2009 18:17 ET

Facility Registration Deadline Looms for Medical Device Makers, According to, LLC

COLUMBIA, MD--(Marketwire - December 7, 2009) - While Americans are gift shopping and tying bows, Benjamin L. England and his team at are helping business owners around the world tie up loose ends for 2009. One group that currently faces a crunch: makers of medical devices who have not yet registered their facilities with FDA for fiscal year 2010. December 31, 2009 is the deadline, and for most companies, filing is not complete without a shiny red fee of $2,008 wrapped around it.

Manufacturers of medical devices -- as well as those who re-label, re-package, re-process, or import medical devices -- must register and list with FDA, but some are exempt from the user fee. Those who develop specifications for devices they distribute but do not manufacture must register, list, and pay the user fee, while initial distributors of imported devices must only register and list. Manufacturers of components that are distributed only to a finished device manufacturer are not required to do any of the above. Contract manufacturers, whose finished device is manufactured to another establishment's specifications and shipped to U.S., must also do all three.

Foreign manufacturers have the added responsibility of naming a U.S. agent and the agent's address for FDA. This address cannot be a postal box or answering service; it must be the name and location of a U.S. citizen or businessperson who can act as liaison between FDA and the foreign firm. has consultants on call who professionally and successfully act as U.S. agents for foreign manufacturers.

In addition to medical device registration, also assists manufacturers of drug products, food and beverage products, and cosmetics with facility registration and U.S. agency obligations. Contact us for help with your registration needs. Let us show you "the way through!"

About was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. specializes in making the complex understandable.

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