federal_register: 2021-25376
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-25376 | Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets | Rule | The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is reclassifying these four types of blood lancets on its own initiative based on new information. | 2021-11-22 | 2021 | 11 | https://www.federalregister.gov/documents/2021/11/22/2021-25376/medical-devices-general-and-plastic-surgery-devices-reclassification-of-blood-lancets | https://www.govinfo.gov/content/pkg/FR-2021-11-22/pdf/2021-25376.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket... |