federal_register: 2018-27237
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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... |