federal_register: 2015-26637

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2015-26637 Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Manufacturing Site Change Supplements: Content and Submission". This draft guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. This draft guidance is not final nor is it in effect at this time. 2015-10-21 2015 10 https://www.federalregister.gov/documents/2015/10/21/2015-26637/manufacturing-site-change-supplements-content-and-submission-draft-guidance-for-industry-and-food https://www.govinfo.gov/content/pkg/FR-2015-10-21/pdf/2015-26637.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Manufacturing Site Change Supplements: Content and Submission". This draft guidance describes the decision-making steps that FDA recommends to...  

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