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U.S. to release 120 medtech classes from premarket requirements

AdvaMed SmartBrief | Jul 01, 2015

In a new final guidance document, the FDA said it would exclude 120 classes of medtech products from premarket review and notification requirements. The FDA said companies will not be required to file a 510(k) and will not be subject to 510(k) requirements. "The FDA believes devices identified ... are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness," according to the guidance. Regulatory Focus (06/30)


EU Council considers changes to medical device regulations

AdvaMed SmartBrief | Jun 30, 2015

Former Medtronic executive joins Waters as president, CEO, board member

AdvaMed SmartBrief | Jun 29, 2015

Integra to spend $312M to buy TEI Medical, TEI Biosciences

AdvaMed SmartBrief | Jun 30, 2015

Acquisition of Zimmer Biomet assets completed by DJO Surgical

AdvaMed SmartBrief | Jul 02, 2015

Follow-on offering could bring in as much as $15M for EnteroMedics

AdvaMed SmartBrief | Jul 01, 2015

IPO could bring in $75M for GC Aesthetics

AdvaMed SmartBrief | Jun 29, 2015

IPO could pull in $135M for ConforMIS

AdvaMed SmartBrief | Jul 02, 2015

Balloon catheter from Bard shows positive results in study

AdvaMed SmartBrief | Jun 30, 2015

Fat grafting device from Acelity debuts in EU

AdvaMed SmartBrief | Jun 30, 2015


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IDE Submissions Workshop

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PMA Submissions Workshop

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510(k) Submissions Workshop

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AdvaMed SmartBrief | Jul 01, 2015

Integrating Human Factors into Medical Device Design Control and Beyond

AdvaMed SmartBrief | Jun 30, 2015




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