The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution and not for "research" or "investigation" uses as invoiced. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. Questions or issues involving import operations, should be addressed to the Division of Import Operations at 30, or email *** For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via the CDRH Import Mailbox email address: *** Product Description: For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)." If a firm and/or a representative of the firm would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address: Food and Drug Administration Division of Import Operations (DIO) 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or via email: DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For more information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning." For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: Request for removal from Detention Without Physical Examination under this Import Alert (REMOVE FROM RED LIST): In order to remove a firm's device from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. Divisions will refer such applications related to this alert to CDRH Imports and Registration & Listing Team, for concurrence. Release of devices subject to detention without physical examination under this import alert: In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment may submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning). DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration & Listing Team. A recommendation for addition to detention without physical examination, including analytical worksheets (if the product was analyzed), labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc., should be forwarded to the Division of Import Operations (DIO). Divisions may detain, without physical examination, the indicated devices from the firms identified on the Red List of this import alert.
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