A few new updates to the Regulatory page.
The average decision time for FDA 510(k) clearance was 113 days in 2008. This is up 30% from 2005. FDA time-frame is supposed to be 90 days.
The increased review time is likely to continue. This a new FDA and there have been concerns raised regarding the 510(k) process. We’ll know more in the coming months. Read more about this from MassDevice Exclusive: FDA Lags on 501(k) Approvals.
“Itâ€™s never too late to learn the basic steps of getting a medical device to market. The regulatory pathway may have some undesired twists and turns . . .” (from MD&DI’s Device Approval 101)
Understanding regulatory pathways is a significant challenge for entrepreneurs and inventors of new medical device products. I recently shared an experience Creo Quality had with a physician who wanted us to help with a 510(k) submission. The doctor might have an idea for the greatest product ever. But without understanding or trusting others to help with a regulatory strategy, this product might never make it to the market.
As the MD&DI article states:
“Too often, regulatory strategies are devised near the end of the product design and development process rather than at the start.”
The article goes on to define the key steps as:
- Define – ensure the product is in fact a medical device according to FDA definition
- Classify – determine if the device is class I, II, or III
- Test – prove the product is safe; prove the product meets requirements; prove the product meets user needs
- Submit – prepare the regulatory submissions according to FDA requirements for the device class
Without a sound regulatory strategy, commercialization will be delayed and costs will increase. If you need help devising a strategy, find someone to help.