NEWS ROOM

See the latest news from our company below or use the search feature. For more information, contact our head office or the Marketing Communications Manager directly at marcom@arazygroup.com.


 

FDA TO REQUIRE NEW VALIDATION DATA FOR LIST OF REUSABLE MEDICAL DEVICES

by Arazy Group | Jun 14, 2017
The US Food and Drug Administration (FDA) has unveiled a list of reusable medical devices for which it will require validation data regarding cleaning, disinfection and sterilization as well as validated instructions for use in premarket notification submissions.

The list has been published in accordance with the requirements established by the 21st Century Cures Act, and the additional information will need to be provided to the FDA as of August 8, 2017.

The FDA says its new requirements will ensure that the premarket requirements for the listed device types are clear and predictable, which will facilitate a more efficient review of 510(k)s.

Contact us today for more information and to discover how regulatory intelligence and registration management system LICENSALE.COM® assists MedTech firms in gaining access to 100+ markets faster and more cost-effectively than ever before.


 
 
 

 

Back to Press Room

latest news
  • Sep 19 2017
    REGULATORY UPDATE - SPD

    Korea: SPD's CB11 was approved for sale with LICENSALE.COM®. ...

    Read More
  • Sep 6 2017
    REGULATORY UPDATE - SPD

    Philippines: SPD's IVD products CBDOT were approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 31 2017
    REGULATORY UPDATE - CORTEX

    USA: Cortex's Dental implants and Prosthetic Devices were approved for sale with LICENSALE.COM®...

    Read More
  • Aug 10 2017
    REGULATORY UPDATE - SPD

    Ethiopia: SPD's CB11, CB9 & CBDOT were approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 8 2017
    REGULATORY UPDATE - XERIDIEM

    Saudi Arabia: Xeridiems' Entuit family was approved for sale with LICENSALE.COM®. ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP