federal_register: 2019-03967
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-03967 | Medical Devices; Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments | Proposed Rule | The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The Agency has determined based on established factors that these devices, which are currently regulated by FDA under product code OYE, no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other class II devices classified under FDA's automated differential cell counter regulation would continue to be subject to premarket notification requirements. FDA is publishing this proposed order to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). | 2019-03-06 | 2019 | 3 | https://www.federalregister.gov/documents/2019/03/06/2019-03967/medical-devices-exemption-from-premarket-notification-class-ii-devices-flow-cytometer-instruments | https://www.govinfo.gov/content/pkg/FR-2019-03-06/pdf/2019-03967.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The Agency has determined based on established... |