federal_register: E9-31307
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E9-31307 | Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products," dated December 2009. As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures commitment letter, FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. The final guidance announced in this document fulfills FDA's commitment to issue guidance called for by the commitment letter. The guidance supercedes the draft guidance of the same title dated September 30, 2008. | 2010-01-06 | 2010 | 1 | https://www.federalregister.gov/documents/2010/01/06/E9-31307/guidance-for-industry-on-new-contrast-imaging-indication-considerations-for-devices-and-approved | https://www.govinfo.gov/content/pkg/FR-2010-01-06/pdf/E9-31307.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products," dated December 2009. As part of the... |