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Final rule prohibits "split predicates" under 510(k) process

AdvaMed SmartBrief | Jul 30, 2014

The FDA has released a final rule disallowing use of "split predicates" under the agency's 510(k) clearance program. The rule states that manufacturers seeking to demonstrate that their new devices are "substantially equivalent" to products already available commercially will no longer be allowed to cite distinct predicate devices that serve a different purpose. MassDevice.com (Boston) (07/29)


Medtronic to pay up to $105M for laser ablation device firm

AdvaMed SmartBrief | Jul 29, 2014

Proposed Sunshine regulations could mean new costs for medtech firms

AdvaMed SmartBrief | Jul 24, 2014

Medtronic agrees to pay $2.8M to settle insulin pump lawsuit

AdvaMed SmartBrief | Jul 28, 2014

ConMed picks former Stryker exec to serve as interim CEO

AdvaMed SmartBrief | Jul 24, 2014

Boston Scientific's drug-coated balloon wins EU approval

AdvaMed SmartBrief | Jul 25, 2014

Medtech firms paid $1.4B in excise taxes in 2013, IRS data show

AdvaMed SmartBrief | Jul 29, 2014

New device uses microscopic laser beams to draw blood

AdvaMed SmartBrief | Jul 30, 2014

Investors pump $172M into smart pill tech developer

AdvaMed SmartBrief | Jul 30, 2014

Teleflex's chronic hemodialysis catheter wins FDA nod

AdvaMed SmartBrief | Jul 24, 2014


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Investigational Device Exemption (IDE) Submission Workshop

AdvaMed SmartBrief | Jul 31, 2014

510(k) Submissions Workshop

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Helping medical technology professionals keep pace with regulatory and compliance issues

AdvaMed SmartBrief | Jul 30, 2014

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AdvaMed SmartBrief | Jul 30, 2014

Premarket Approval (PMA) Submissions Workshop

AdvaMed SmartBrief | Jul 29, 2014




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