FDA issues new guidance on medical device user fee refunds and exceptions-massdevice: The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.
Wednesday, April 3, 2013
FDA issues new guidance on medical device user fee refunds and exceptions
FDA issues new guidance on medical device user fee refunds and exceptions-massdevice: The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.
