FDA Releases Most Recent Accounts of MDUFA Negotiations, Unveils Upcoming Regulations

The US Food and Drug Administration (FDA) released a cache of meeting minutes from the February negotiations over the Medical Device User Fee Act (MDUFA) reauthorization language.

The minutes give a timely look in to the negotiations over what many deem must-pass legislation. The minutes also give insight into future FDA medical device regulation.

Minutes from the 17 February negotiations indicate that FDA is committed to exempting "additional low risk medical devices from premarket notification by the end of 2013," and will issue regulations to do so by 2015. FDA also proposed the development of "a transitional In Vitro Diagnostics (IVD) approach for the regulation of emerging diagnostics."
The 16 February negotiations primarily focused on a proposed discretionary fee waiver for Laboratory Developed Tests (LDTs) and how FDA should apply those waivers.
The 14 February negotiations primarily focused on establishment and premarket authorization (PMA) application fee structures.
The 10 February negotiations saw industry propose a MDUFA fee structure, which FDA agreed in concept to and agreed to evaluate. The meeting also addressed fee over-collections, which FDA proposed minimizing by adjusting fees annually to "better estimate the targeted fee collections for each year."
The 8 February negotiations were primarily spent wrangling over the proposed MDUFA fee structure.

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 17, 2012

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 16, 2012

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 14, 2012

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 10, 2012

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 8, 2012

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