federal_register: 02-3281
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 02-3281 | Medical Devices; Reclassification of the Cutaneous Carbon Dioxide (PcCO2) and the Cutaneous Oxygen (PcO2) Monitor | Proposed Rule | The Food and Drug Administration (FDA) is proposing to reclassify the cutaneous carbon dioxide (PcCO<INF>2</INF>) monitor from class II (performance standards) into class II (special controls). FDA is also proposing to reclassify the cutaneous oxygen (PcO<INF>2</INF>) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reproposing the reclassification of the cutaneous oxygen (PcO<INF>2</INF>) monitor for all other uses from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled "Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO<INF>2</INF>) and Oxygen (PcO<INF>2</INF>) Monitors; Draft Guidance for Industry and FDA" which would serve as the special control if this proposal becomes final. These reclassifications are being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997. | 2002-02-12 | 2002 | 2 | https://www.federalregister.gov/documents/2002/02/12/02-3281/medical-devices-reclassification-of-the-cutaneous-carbon-dioxide-pcco2-and-the-cutaneous-oxygen-pco2 | https://www.govinfo.gov/content/pkg/FR-2002-02-12/pdf/02-3281.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to reclassify the cutaneous carbon dioxide (PcCO<INF>2</INF>) monitor from class II (performance standards) into class II (special controls). FDA is also proposing to reclassify the cutaneous oxygen... |