federal_register: E8-23712
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-23712 | Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products." As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures, FDA agreed to publish draft guidance by September 30, 2008, for medical imaging devices with "contrast agents or radiopharmaceuticals." FDA intends this draft guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. Particularly this guidance focuses on approaches in developing new contrast indications for imaging devices for use with already approved imaging products. FDA intends for the recommendations in this guidance to promote timely and effective review of, and consistent and appropriate regulation and labeling for imaging drugs and devices. | 2008-10-07 | 2008 | 10 | https://www.federalregister.gov/documents/2008/10/07/E8-23712/draft-guidance-for-industry-on-new-contrast-imaging-indication-considerations-for-devices-and | https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/E8-23712.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products." As part of the Medical Device User... |