{"database": "openregs", "table": "federal_register", "rows": [["2018-27237", "Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff.\" This 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 when determining whether to conduct an establishment inspection prior to approval of a site change supplement.", "2018-12-17", 2018, 12, "https://www.federalregister.gov/documents/2018/12/17/2018-27237/manufacturing-site-change-supplements-content-and-submission-guidance-for-industry-and-food-and-drug", "https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/2018-27237.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff.\" This guidance...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2018-27237"], "units": {}, "query_ms": 0.544870039448142, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}