Hi all,
Congratulations! We have completed MDD & AMDD. I found an interesting topic we should discuss or at least we should have idea about it, "Cost and Time of Device Clearance/Approval".
How much does FDA approval cost for new medical devices?and how long it takes to get approval for your medical device? (note it depends on too many things i.e 510(k), PMA)
Please share with us your experience about Cost and Time of Device Clearance/Approval! or search on the web and look at the numbers!
thanks
Hint: emergobyul/resources/research/fda-510k-review-times-research
ryortho/breaking/fdas-510k-clearance-performance-remains-average
The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days. Just recently, my company received 510k clearance for a device 65 days after submitting the 510k. However, this came as a shock to us, because it usually takes much longer than this.
https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452519.htm
emergobyul/resources/research/fda-510k-review-times-research
ryortho/breaking/fdas-510k-clearance-performance-remains-average
Yes as @srg mentioned the 501k rates. Just to add ot the conversation as per Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV) through 2022:
2018 standard rate for 510k is $10,5666 and small business is $2,642
2018 standard rate for PMA is $310, 764 and for small business is $77,691
I do think its fair for small businesses to receive a discounted rate. It will be interesting to see what the rates will be moving forward in 2023.
https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452519.htm
