Small businesses are still given a break for first time applications . Their fiscal year begins in October so if passed, the new rates could be in effect within months for the fiscal year 2011. By comparison what companies spend to get to this point to file may not look that substantial.
Now with all the devices that report data, there’s a lot more to the processes and even an attempt to possibly have less reliance on outside agencies help perform some of their evaluations, especially in the area of radiation treatment. They might just need to get some in house code heads around to help out here as devices and their software are very specific in nature and are getting more diverse as they are produced in the “brain” department, in other words, the software an algorithms that make them work.
Medical Device Analysis Outsourcing to Third Parties Under Review at the FDA – Are Some Potentially Lethal Algorithms Being Missed In the Process
One other little note from a couple months ago, the top medical device regulator left the FDA and went to work at Microsoft, which might be a very good thing as she learns the other side of the fence to create collaborative efforts in the software needed at the FDA. BD
FDA Medical-Device Regulator Leaves to Take Position at Microsoft Health Solutions Group – Director of Regulations and Policy
The Food & Drug Administration proposes to raise user fees paid by medical device makers to determine how they should apply for clearance or approval from the federal watchdog.
The Food & Drug Administration is proposing to raise the user fees it charges medical device makers seeking to have their devices approved for market.
The FDA's 513(g) request for classification process allows device makers to ask the federal watchdog agency how their devices should be classified and what protocol they should use to seek clearance or approval. The agency sets two tiers, one for businesses with more than $100 million in sales and another, lower fee rate for smaller businesses.
The fee for fiscal year 2010 is $2,941 for large businesses; the agency is proposing to raise that by 17.7 percent to $3,191 for fiscal year 2011, which begins in October. The small business fee, currently $1,470, is slated to rise to $1,595 during FY2010, an 8.5 percent increase.