federal_register: 04-24591
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-24591 | Medical Devices; Reclassification of the Iontophoresis Device | Notice | The Food and Drug Administration (FDA) announces an opportunity to submit information and comments concerning FDA's intent to initiate a proceeding to reclassify those iontophoresis devices currently in class III (premarket approval) into class II (special controls). An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for diagnostic or other uses. Elsewhere in this issue of the Federal Register, FDA is withdrawing the proposed rule the agency issued in the Federal Register of August 22, 2000 (65 FR 50949) (the August 2000 proposed rule). | 2004-11-04 | 2004 | 11 | https://www.federalregister.gov/documents/2004/11/04/04-24591/medical-devices-reclassification-of-the-iontophoresis-device | https://www.govinfo.gov/content/pkg/FR-2004-11-04/pdf/04-24591.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) announces an opportunity to submit information and comments concerning FDA's intent to initiate a proceeding to reclassify those iontophoresis devices currently in class III (premarket approval) into class II... |