FDA Compliance - Techlink



FDA Initial Importer is a FDA requirement.

Foreign manufacturers must meet applicable United States (U..S.) medical device regulations in order to import devices into the U.S. even if the product is authorized for marketing in another country. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval, if applicable. In addition, the foreign manufacturers must designate a FDA Initial Importer and United States agent.

An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

Initial importers are also subject to Medical Device Reporting, Reports of Corrections and Removals, and Medical Device Tracking under 21 CFR 821, if applicable. Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions. The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and non MDR events) must be forwarded to the manufacturer. Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain.

Most importers ask that domestic customhouse brokers (or filers) complete these forms electronically and make the submissions on their behalf. Filers have access to the Operational and Administrative Systems for Import Support (OASIS), the FDA computerized import system. The OASIS program is an electronic interface between FDA and the CBPs Automated Commercial System (ACS). OASIS is an on-line interactive and automated system, which replaced the process of reviewing the paperwork for import entries manually.

When an entry is filed with CBP, a copy of the entry is also provided to the local FDA district office. The FDA district office then determines if the product complies with FDA requirements. The FD&C Act authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. If a product appears to be out of compliance, the FDA district office will issue a “Notice of FDA Action” specifying the nature of the violation to the owner or consignee. The owner or consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another “Notice of FDA Action” refusing admission to the product. The product then has to be exported or destroyed within 90 days. Failure to do so within 90-days may result in issuance of a Customs Redelivery Notice and an assessment for liquidated damages for up to 3 times the value of the lot.

Upon entry, FDA may examine certain devices to assure their safety and effectiveness. When this occurs, FDA will issue a notice to the importer of a record on a form titled “Notice of FDA Action.” Sampling may involve examining the product at the port of entry or physical collection of a statistical portion of the lot for analysis by an FDA laboratory. If the sample is violative, or if the sample is determined to be out of compliance with required specifications, the device will be detained and the importer of record will be issued a “Notice of FDA Action” indicating that the article is being detained due to the appearance of a violation under the FD&C Act. The “Notice of FDA Action” will state the specific violations to the FD&C Act.

Under certain conditions, the importer of record of a device that has been detained, is given an opportunity to submit application for authorization to bring the device into compliance with the FD&C Act. If FDA permits reconditioning, another sample may be collected and analyzed after reconditioning. If the device is then determined to be in compliance, it will be released. Only the FDA District Office at the port of entry has the authority to authorize reconditioning and/or to release the shipment. You must provide the appropriate documentation or bring the products into compliance under the authorization from the District Office. When contacting the District Office, you should ask for the Compliance Office and provide the entry number and/or sample number as a reference.

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