federal_register: E8-29330

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-29330 Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval-the Premarket Approval Supplement Decisionmaking Process; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Modifications to Devices Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making Process." The purpose of this guidance is to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified. 2008-12-11 2008 12 https://www.federalregister.gov/documents/2008/12/11/E8-29330/guidance-for-industry-and-the-food-and-drug-administration-modifications-to-devices-subject-to https://www.govinfo.gov/content/pkg/FR-2008-12-11/pdf/E8-29330.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Modifications to Devices Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making Process." The purpose of this guidance is to help industry...

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