FDA Amends and Extends Regulations on Medical Device Registration and Listing
The FDA recently issued a final rule amending several portions of its regulations governing the requirements for medical device companies to register with FDA and provide a list of their products. The amended regulations take effect October 1, 2012.
First, the final rule amends the regulations to conform to legislation from 2007 requiring that registration and listing information be provided to FDA electronically, unless FDA grants a waiver. This change should not affect the practice of most medical device firms given that the FDA's electronic registration system, known as FURLS, has been available since October, 2007.
Second, the requirements for foreign manufacturers were amended so that they must identify all known importers of their devices into the US and every firm that imports or offers to import their devices into the US. Further, the amendments remove exemptions for devices imported into a foreign trade zone for re-export and for components imported under certain conditions.
Third, the regulations were amended so that contract manufacturers and sterilizers of medical devices must now register and list their devices. Fourth, exempt devices must now be registered by product code rather than classification name and number. Fifth, the new regulation codifies the existing practice to require the device listing to include the number for the 510(k) clearance or humanitarian device exemption (HDE).
Sixth, the regulations require the registering firm to identify a contact person to administer the firm's FURLS account. Seventh, the type of operations in which a firm is engaged will now be entered only with the device listing, from where it will be migrated automatically to the registration section. Eighth, the regulations are amended to conform to legislation requiring certain manufacturers to pay the annual registration fee. Ninth and finally, the definition of "restricted device" is amended to reflect more accurately the FDA's statutory authority to restrict devices.