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Patient, Consumer Groups Decry Lack Of User Fee Funding For Post-Market Surveillance

Non-industry stakeholders criticized the medical device user fee agreement for not giving FDA enough funding, particularly to enhance post-market surveillance programs, during an FDA public meeting on user fee reauthorization.

Patient and consumer advocacy groups criticized proposed device user fees as being too low and stressed the need for additional funding for post-market surveillance programs during a March 28 public meeting on device user fee reauthorization.

Under the medical device user fee agreement, reached by FDA and industry negotiators in February, the agency would collect $595 million in fees, plus inflation, from industry from fiscal 2013...

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