• April 10, 2019
  • WTO

US | Medical Devices - Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments



Title of document
Medical Devices; Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments (4 page(s), in English)

Description
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).

Notifying member: United States of America

NotificationG/TBT/N/USA/1463

Objective tag
Cost saving and productivity enhancement

Documents


Agency responsible
Food and Drug Administration (FDA), Health and Human Services (HHS) [1491]

Timing:

  • Submission: 08/04/2019
  • Reception: 09/04/2019
  • Distribution: 10/04/2019
  • Final date for comments: 06/05/2019
  • Proposed date of adoption: N/A

                   

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