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Compliance In Focus


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Posted by John Lehmann on Fri, Jun 03, 2016

China-Made Device Knock Offs a Source of Concern

Medtech companies in the U.S. are concerned about Chinese device manufacturers stealing their intellectual property and making knock-offs that replicate American devices.  However, these devices are not as safe according to Advamed.

Topics: Medical Devices, AdvaMed, China-Made, Kock Offs, Ralph Ives

Posted by John Lehmann on Wed, Mar 04, 2015

AdvaMed: Don’t Change 510(k) Rules

AdvaMed is pushing back on an initiative in Congress to have the FDA to tighten policies for approving modifications of on-the-market medical devices.  In an article in FierceMedicalDevices, AdvaMed contends there is nothing wrong with the current 510(k) program.  AdvaMed contends the system has worked well for 16 years, so no changes are needed.

Topics: AdvaMed, FierceMedicalDevices, FDA, 510(k)

Posted by John Lehmann on Wed, Mar 04, 2015

Taking Medical Device Opposition Directly to Employees

We have written many blogs on the medical device tax and thought we have covered almost angle on this issue.  However, we thought this article in FierceMedicalDevices brought a new strategic twist to the discussion. There has been a concerted effort by the industry to repeal the 2.3% medical device revenue since it was introduced in the Affordable Care Act.

Topics: AdvaMed, Medical Device Tax, Affordable Care Act

Posted by John Lehmann on Wed, Mar 04, 2015

What Should the Medical Device Industry Do Now?

Topics: AdvaMed, OneMedForum, Medical Device Industry

Posted by Brandy Chittester on Wed, Mar 04, 2015

FDA Needs to Revise UDI - Do You Agree?

While the goal was for FDA to develop the proposed Unique Identification Rule in close collaboration with the clinical community, patient and consumer groups, and with the data from four pilot studies- is it possible FDA missed the mark? According to the industry group The Advanced Medical Technology Association (AdvaMed) changes need to be made to the agency’s rule to make it useful, cost-effective and practical.

Topics: AdvaMed, UDI, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

New FDA User Deal: More Challenges or Opportunity?

Like most new pieces of legislation, the FDA user fee deal, signed into law by President Barack Obama in July provides medical device companies with both challenges and opportunities.

Topics: AdvaMed, User Deal, UDI Provisions, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Changes Urged on 510(k) Plans

Discussion on the FDA’s 510(k) program remains a very popular topic.  According to an article in MD+DI, industry groups are urging major changes on the FDA’s draft on evaluating substantial equivalence in 510(k)s.  Not surprisingly, Public Citizens is asking the agency to delay the guidance because they feel it’s overly permissive.

Topics: AdvaMed, Public Citizens, 510(k)

Posted by John Lehmann on Wed, Mar 04, 2015

Do The FDA & Medical Device Industry Finally Agree?

The tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act (MDUFMA) is long awaited good news! IMARC covered the story of how the FDA missed the MDUFMA proposed deadline, January 15th, in a previous blog. But, luckily it looks like the medical device industry and the FDA were able to find common ground.

Topics: AdvaMed, FDA

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