[DOWNLOAD] "Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition)" by The Law Library ~ Book PDF Kindle ePub Free
eBook details
- Title: Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- Author : The Law Library
- Release Date : January 06, 2018
- Genre: Law,Books,Professional & Technical,
- Pages : * pages
- Size : 287 KB
Description
The Law Library presents the complete text of the Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018
The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.” This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the devices.
This ebook contains:
- The complete text of the Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure
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