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MDUFA 2012: A Devicemaker’s Guide to New Provisions in the Law

November 2012
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You’ve probably read the headline: Under MDUFA 2012, the FDA’s user fees will more than double. But the law does much more than that. It makes major changes to the way the agency regulates devicemakers – touching on everything from approvals to inspections.

You could spend days or even weeks reading and digesting the regulatory changes devicemakers face under the new MDUFA law – changes that may upend the way you do business. Or you can let us do that work for you.

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Each time it’s reauthorized, the MDUFA law lays out a long list of marching orders for the FDA to follow in developing new regulations for devicemakers. This year, the list includes:

  • New authorizations for the FDA to enter into agreements with foreign countries to harmonize requirements and share inspections data
  • Revised requirements for “de novo” determinations
  • Provisions to allow the director of CDRH, in consultation with the FDA  Commissioner, to administratively reclassify some devices 
  • Details on the long awaited Unique Device Identifier proposed regulations
  • New incentives to encourage testing of medical products in pediatric patients
  • A new definition of the ‘least burdensome’ provisions applied to PMA and 510(k) applications
  • The impact of the revised recall audit requirements
  • Clarification of FDA policy on custom medical devices
  • New guidelines on how the FDA will calculate its decision deadlines
  • Procedures and mandates for scheduling meetings with the FDA when an application falls behind
  • A congressional directive that the FDA audit its entire device review process
  • And more.

Don’t waste countless hours researching all the changes MDUFA has in store for your business. We’ve done the work for you with MDUFA 2012: A Devicemaker’s Guide to New Provisions in the Law.

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MDUFA 2012: A Devicemaker’s Guide to New Provisions in the Law is available in print or PDF formats for $377 each.

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