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.


 

HAVE YOUR SAY ON CLASS II DEVICE PREMARKET NOTIFICATION EXEMPTION PROPOSAL

by Arazy Group | Mar 17, 2017
The US Food and Drug Administration (FDA) is requesting public comments on a list of 1,003 class II devices that it is proposing to exempt or partially exempt from the premarket notification [510(k)] requirements.

The FDA has said it believes that the devices, which are published in the Federal Register, are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of their safety and effectiveness. 

Medical devices that are exempt from 510(k) requirements are not exempt from other regulatory controls. MedTech firms must ensure that all medical devices are manufactured under current good manufacturing practice requirements, suitable for the intended use, adequately packaged and properly labelled. All devices must also have establishment registration and device listing forms on file with the FDA.

Comments on the proposed list should be submitted no later than May 15, 2017.  Instructions on doing so can be found in the Federal Register Notice. The FDA will review comments and then consider whether the list of devices should be modified prior to publication of its final determination in the Federal Register.

Contact us today to discuss the FDA’s proposal 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
  • Jun 27 2017
    2017 RAPS: DON’T MISS INVALUABLE INSIGHTS ON REGULATORY STRATEGIES FOR MARKET ACCESS

    MedTech regulatory affairs professionals managing the launch of products in new markets and maintaining market approval globally will benefit from the invaluable insights shared during the ‘Regulatory Strategies for Market Access’ session at this year’s R...

    Read More
  • Jun 13 2017
    FDA TO REQUIRE NEW VALIDATION DATA FOR LIST OF REUSABLE MEDICAL DEVICES

    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 subm...

    Read More
  • Jun 11 2017
    SOUTH AFRICA: NEW REGULATORY AUTHORITY OVERSEES MEDICAL DEVICES

    Medical devices in South Africa are now regulated by the newly established South African Health Products Regulatory Authority (SAHPRA), which has replaced the Medicines Control Council (MCC)....

    Read More
  • Jun 7 2017
    FDA EXTENDS UDI COMPLIANCE DEADLINES FOR LOW-RISK MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has extended the compliance deadlines for the unique device identification (UDI) system requirements for certain class I and unclassified medical devices from September 24, 2018 to September 24, 2020....

    Read More
  • Jun 5 2017
    AUSTRALIA: CONSULTATION ON COMPARABLE OVERSEAS REGULATORS FOR MEDICAL DEVICES OPENS

    Australia’s Therapeutic Goods Administration (TGA) is seeking comments from the MedTech industry and regulators on the use of marketing approval by comparable overseas regulators for medical devices in overseas markets to support the inclusion of them in ...

    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