US | Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances

Title of document
Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances (3 page(s), in English)

Description
The Food and Drug Administration (FDA or we) is classifying the auto titration device for oral appliances into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the auto titration device for oral appliances' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Notifying member: United States of America

Notification: G/TBT/N/USA/1466

Objective tag
Protection of human health or safety

Documents

• 19_2122_00_e.pdf

Agency responsible
Food and Drug Administration (FDA), Health and Human Services (HHS) [1492]

Timing:

• Submission: 10/04/2019
• Reception: 11/04/2019
• Distribution: 11/04/2019
• Final date for comments: N/A
• Proposed date of adoption: N/A