By David Lennarz, Vice President and Co-Founder of Registrar Corp
On Monday, February 16, 2015, the U.S. Food and Drug Administration (FDA) purged approximately 2,628 medical device establishments that did not complete their annual registrations by the deadline from its registration database. Owners and operators of companies that produce and distribute medical devices for use in the United States are required to register with FDA and review their listing information between October 1 and December 31 each year. On December 30, 2014, before the fiscal year 2015 registration deadline, there were approximately 24,123 device establishments in FDA’s database. On February 18, 2015, the number had been reduced to approximately 21,495.
Failure to register a device establishment with FDA is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act). Devices shipped to the U.S. by an unregistered establishment may be denied entry. FDA may hold the devices at the port of entry until the establishment is properly registered.
Medical device establishments that did not register with FDA between October 1 and December 31, 2014, should refrain from distributing devices in the U.S. until the establishment is registered with FDA and its devices are listed. Registrar Corp, a U.S. FDA compliance firm, can properly register an establishment and list its devices. For assistance with registration or other FDA requirements for medical devices, contact Registrar Corp at +1-757-224-0177, or receive help from a Regulatory Advisor 24-hours a day at http://www.registrarcorp.com/LiveHelp.
