Medical Devices
Import Alert 89-08
Import Alert 89-08: Detention of Class III Medical Devices without a Premarket Approval
Background
FDA reviews imported medical devices regularly to ensure that all required approvals and clearances, registrations and product listings have been completed. When FDA finds medical devices that lack required approvals or clearances, it will add the foreign manufacturer and its products to this Import Alert.
How do Firms get on this Import Alert?
Companies that have designed and marketed alternative or novel medical without first obtaining expert help in identifying and complying with FDA medical device approval or clearance requirements can expect to find their devices and they foreign manufacturing sites added to this Import Alert. Medical devices are designated by law as Class III, requiring a Premarket Approval (PMA) unless FDA has expressly exempted that requirement. Most novel devices do not enjoy that exemption and so they are treated under the law as requiring the PMA.
Effects on Businesses Involved
Correcting product labeling and marketing materials and preparing and filing any applicable Premarket Approval or Premarket Notification will take a significant amount of time and money, and should not be attempted without the advice of counsel. Additionally, companies may experience delays in importation of other products from the listed companies. FDA often attempts to find similar violations with other products, which can slow down other, legal shipments into the U.S.
How do Companies get off this Import Alert?
Obtaining removal from this Import Alert will first require a detailed regulatory review of the medical devices and their labeling and marketing materials to identify the regulatory requirements under the law. Then, by relabeling or modifying the marketing materials and/or preparing and submitting necessary evidence and data to FDA proving the product can be used safely and effectively we can provide that information to FDA in the form of an Import Alert Petition to remove the foreign manufacturer and its products. For this Import Alert, affected firms should seriously consider requesting an Import Alert Petition Viability Review to determine the next critical steps.
