View Cart  
MDUFA-2012-A-Devicemakers-Guide-To-New-Provisions-In-The-Law.png

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

$377.00
November 2012
240
View
Also Available:

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.

Order Today

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.

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

Satisfaction Guaranteed
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy within 30 days (in resalable condition), and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

For more information please contact Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578
Email:  customerservice@fdanews.com