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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.

 

 

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