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FDA offers guidelines on device ID rule, de novo review process

AdvaMed SmartBrief | Aug 15, 2014

The FDA has released its final guidelines on how small firms may satisfy the unique device identifier rules, including information related to the appearance of UDIs, rule exceptions and record-keeping standards. The agency also issued a draft document meant to guide companies when submitting Class III medical devices under the agency's de novo review program. MassDevice.com (Boston) (08/14)


Pentagon taps Abbott to develop TBI detection system in $19.5M deal

AdvaMed SmartBrief | Aug 18, 2014

Medtronic MiniMed reaches settlement deal with J&J unit

AdvaMed SmartBrief | Aug 14, 2014

TAVI device used for first time in tricuspid valve replacement in U.S.

AdvaMed SmartBrief | Aug 19, 2014

China proposes use of generic names for medical devices

AdvaMed SmartBrief | Aug 18, 2014

CardioMEMS' 11-year payoff worth the wait for Boston Millennia Partners

AdvaMed SmartBrief | Aug 14, 2014

Greatbatch to boost innovation efforts with CCC Medical buy

AdvaMed SmartBrief | Aug 13, 2014

Guidelines on home-use device development finalized by FDA

AdvaMed SmartBrief | Aug 15, 2014

Dismissal of pain-pump lawsuit against 4 medtech firms upheld

AdvaMed SmartBrief | Aug 13, 2014

Second Sight Medical plans to go public to raise $32M

AdvaMed SmartBrief | Aug 14, 2014


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AdvaMed SmartBrief | Aug 20, 2014

510(k) Submissions Workshop

AdvaMed SmartBrief | Aug 20, 2014

Download new tool kit: The Value of Medical Technology to Treat Cataracts

AdvaMed SmartBrief | Aug 19, 2014

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AdvaMed SmartBrief | Aug 19, 2014

Premarket Approval (PMA) Submissions Workshop

AdvaMed SmartBrief | Aug 18, 2014




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