<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
Compliance In Focus
Posted by John Lehmann on Mon, Aug 20, 2012

New FDA User Deal: More Challenges or Opportunity?

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

According to an article in MassDevice, a new report by PricewaterhouseCoopers(PwC) indicates the main challenges of the User Deal to include:

  • FDA’s new authority to change the risk classification on a medical device.
    • This was a major concession made by the medical device industry during their negotiations with the FDA.
  • How prepared companies for the new UDI provisions, which could require serialization not only of finished products but also constituent components.
    • This may require manufacturers to rethink sourcing and supplier monitoring processes

The PwC report also outlines some advantages to the industry:

  • FDA’s decision to sync FDA requirements with other countries’ regulatory branches and to allow the use of data collected from outside the country in device review applications.
  • Other opportunities include the way the FDA asks companies for more information during the pre-market approval process.

AdvaMed feels the new user fee deal is a win for everyone – patients, med-tech companies and the FDA.  Stephen Ubl, president and CEO feels that this is the first user fee agreement that is focused on total review times on both a PMA and 510(k).

There seems to be both challenges and opportunities for the medical device industry.  Do you feel the opportunities outweigh the challenges?  Share your thoughts with us.

Photo Credit: Sepehr Ehasani

Topics: AdvaMed, User Deal, UDI Provisions, FDA


Posts by Topic: