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Compliance In Focus
Posted by Brandy Smith on Thu, Sep 20, 2012

Who is Updating Medical Device Review Guidelines?

“The new proposal aims to fulfill a European Parliament request for more stringent med-techupdating review guidelines scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.”  Sound familiar? You might be surprised to learn that this excerpt was not in reference to FDA.

In fact, the recent passage came from an article posted on MassDevice which speaks to the European Commission’s latest efforts. While these latest efforts have also been shared by FDA, the article points out that EU “may be taking some cutes from FDA in bolstering regulatory oversight.”

How might this effect the industry? Well, the article is appropriately titled, “Europe’s more stringent medtech review may bring costly delays.” While some may see this further checks and balance as a victory for patient protection, others may see it as one more road block on the pathway to market.

It seems as if FDA and EU have to walk a fine line between and focus on:

  • Regulations that are comprehensive, without out being  burdensome
  • Overall process transparency that gives the public and industry clarity
  • Stream-line the pathway to approval without taking away from proving safety and efficacy
  • Protect patients, while at the same time giving them quick access to life-saving innovations

What is the perfect balance? How can both FDA and EU improve processes for a win-win? We want to hear your suggestions, post below.

Photo Credit: Nic’s events

Topics: Medical Device Review Guidelines, MassDevice, FDA


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