FDA eCopy is a printing and shipping service for FDA submissions of a 510(k), pre-submission request, De Novo application, etc. This new service prints and ships your FDA eCopy submission so you can avoid the hassle. We use a high-speed (50+ ppm) printer so we can print a 1,000-page FDA submission in 20 minutes. We have the eCopy validation software loaded on all our computers. All the flash drives are pre-formatted. We have every size of 3-ring binder from 1″ to 5″. FedEx stops by every day between 4:00pm and 5:00pm to pick-up express shipments for the FDA. If we need a later cut-off time, the FedEx shipping location is only 4.4 miles (7.1 km) away and the truck does not leave until 6:25pm. There’s also zero traffic in rural Vermont.
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