MASSDEVICE ON CALL — The FDA last week issued final guidance on agency and medical device industry protocol for addressing requests for information and applicable user fees.
Certain requests for classified information, dubbed 513(g) requests, are unilaterally subject to user fees without exception for pediatric devices or for requests from state or federal agencies, according to the guidance.
Standard fees for 2012 range from more than $3,400 for the standard rate and more than $1,700 for small businesses. The rates are up from nearly $3,200 standard and nearly $1,600 for small businesses in 2011.
513(g) requests include "information respecting the class in which a device has been classified or the requirements applicable to a device," according to an agency release.
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