Federal register
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The Food and Drug Administration (FDA) is issuing this final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) that require all persons who submit a premarket notification (510(k)) to provide to FDA, as part of the submission, an adequate summary (510(k) summary) of any information respecting safety and effectiveness or a statement (510(k) statement) that such information will be made available upon request by any person. This rule also implements the requirement of the SMDA that 510(k) submitters claiming substantial equivalence to a class III preamendments device for which FDA has not yet called for premarket approval submit a class III summary and certify that they have conducted a search of safety and effectiveness data. In addition, this rule amends the device regulations governing the confidentiality of certain premarket notification submissions to conform to the SMDA. This rule also provides that persons who submit a premarket notification must certify that, to the best of their knowledge, all information is truthful and accurate and that no material fact has been omitted.
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This final rule amends the existing regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank), codified at 45 CFR part 60, authorizing the reporting and release of information concerning: Payments made for the benefit of physicians, dentists, and other health care practitioners as a result of medical malpractice actions or claims; and certain adverse actions taken regarding the licenses and clinical privileges of physicians and dentists. This final rule revises sections 60.2 and 60.7 to require reporting only by entities which make medical malpractice payments, deleting the reference to reporting by persons (individuals). It also clarifies the reference to "professional society" in section 60.9.
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The Food and Drug Administration (FDA) is publishing a letter sent to known manufacturers of blood establishment computer software products. In the letter, FDA advised these manufacturers that it considers these computer software products to be devices under the Federal Food, Drug, and Cosmetic Act (the act) because these products aid in the prevention of disease by identifying unsuitable donors and preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing use. The letter, accompanied by a registration package and device listing was intended to notify manufacturers of the requirements of the act, to facilitate registration of these manufacturers as medical device manufacturers, and to further ensure the safety of the blood supply.
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The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.
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This document revises the responsibilities, functions, relationships, and authorities of the Assistant Secretary of Defense for Health Affairs ASD(HA). The principal revision, the assignment of the Health Affairs functions under the Under Secretary of Defense for Personnel and Readiness is consistent with Section 903 of the FY 1994 Defense Authorization Act.