Federal register
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The Food and Drug Administration (FDA) is proposing reporting and recordkeeping regulations to implement certain sections of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the FDA Export Reform and Enhancement Act of 1996. The proposed rule would require an importer to report to FDA each time it imports an unapproved or otherwise violative article that is to be exported after further processing or incorporation into another product in the United States and to keep records to ensure that the article is so processed or incorporated and then exported, and that any portion of the import that is not exported is destroyed.
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The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.
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In the October 5, 1998 issue of the Federal Register (63 FR 53446), we published a notice announcing the annual update to the hospice wage index. The wage index is used to reflect local differences in wage levels. That update was effective October 1, 1998 and is the second year of a 3-year transition period. This notice corrects errors made in that document.
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The Food and Drug Administration (FDA) is proposing to classify both liquid chemical sterilants intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use, and general purpose disinfectants intended to process noncritical medical devices and equipment surfaces. Under the proposal, liquid chemical sterilants would be classified into class II (special controls) and general purpose disinfectants would be classified into class I (general controls). ⋯ After considering public comments on the proposed classification, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.
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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry." This guidance is intended to provide recommendations for information that is to be included in premarket submissions--investigational device exemption (IDE), premarket approval application (PMA), and 510(k) submissions for medical devices that either contain or are exposed to animal-derived materials during manufacturing.