FDA update March 20, 2012

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 28, 2012

New USER FEES FOR 2012-13, Huge Jump in ESTABLISHMENT REGISTRATION FEES ARE COMING.

FDA reported that they have concluded negotiations with Industry. On February 17, 2012 they reached agreement with all four industry associations Industry on the final details of the fee structure and minor changes to the draft Commitment Letter and legislative language. The negotiated agreement is undergoing Administration review. Once cleared by the Administration, FDA will publish a summary of the agreement in a Federal Register (FR) Notice and post additional information on the FDA website.FDA will hold a public meeting very soon thereafter. Following a 30-day comment period beginning with publication of the FR Notice, FDA will consider all comments, make any changes if warranted, and then submit their formal recommendations to Congress through the Secretary. FDA will also brief Congressional committees.

FDA outlined several new or changed elements of the draft Commitment Letter since the update provided at the previous stakeholder meeting which are as follows:

  • FDA proposed and Industry agreed with a discretionary fee waiver provision that allows the Secretary, in the Secretary’s discretion, to waive or reduce application and registration fees in the interest of public health.
  • This is intended to be utilized if FDA changes its policy of enforcement discretion for laboratory developed tests (LDTs) during MDUFA III. Fee waivers are capped annually at 2% of the total fees, consistent with Dr. Shuren’s recent statement at an Energy and Commerce subcommittee hearing that FDA’s planned regulatory approach for LDTs would likely involve less than $3 million in annual costs. The provision will sunset at the end of MDUFA III.
  • In general, application fees will increase by 2% over the fiscal year 2012 fees, before any inflation adjustment. Of note, 510(k) submission fees will increase slightly more as they will now be based on 2% of annual PMA fees rather than the current 1.84%.
  • The bulk of the increase in revenue will come through establishment registration fees, which will rise from approximately $2400 to approximately $3900 before any inflation adjustment.

Any questions on this FDA update please email us at info@mdiconsultants.com and Ref:Minutes on MDUFA III

Or you can go to the following link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm295420.htm?source=govdelivery