federal_register: E9-8022

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E9-8022 Medical Devices; Order for Certain Class III Devices; Submission of Safety and Effectiveness Information Notice The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA a summary of, and a citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information concerning the devices which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). FDA is requiring the submission of this information in order to determine, for each device, whether the classification of the device should be revised to require the submission of a PMA or a notice of completion of a Product Development Protocol (PDP), or whether the device should be reclassified into class I or II. 2009-04-09 2009 4 https://www.federalregister.gov/documents/2009/04/09/E9-8022/medical-devices-order-for-certain-class-iii-devices-submission-of-safety-and-effectiveness https://www.govinfo.gov/content/pkg/FR-2009-04-09/pdf/E9-8022.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA a...  

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