For further reading, feel free to look up 510k's and the FDA approval process for medical devices. TL;DR - 510k's are an approval method used by the FDA in which a product need only prove it is...
For further reading, feel free to look up 510k's and the FDA approval process for medical devices.
TL;DR - 510k's are an approval method used by the FDA in which a product need only prove it is "substantially equivalent" to a currently-approved device. There is no mechanism to prevent a 510k being awarded based on a comparison to another product that also received a 510k. Devices that are awarded a 510k do not need pre-market approval by the FDA like non-510k devices.
Additionally, in November of last year the FDA acknowledged the concerns many people have with the 510k process and instituted a procedural change that allowed the 510k to continue to be awarded, but required the standard against which new devices are measured to be "objective performance criteria", a characteristically vague concession that side steps the core problem.
It's linked near the top of this article, but the same author also wrote a good article about uBiome last week: Insiders describe aggressive growth tactics at uBiome, the health start-up raided by...
For further reading, feel free to look up 510k's and the FDA approval process for medical devices.
TL;DR - 510k's are an approval method used by the FDA in which a product need only prove it is "substantially equivalent" to a currently-approved device. There is no mechanism to prevent a 510k being awarded based on a comparison to another product that also received a 510k. Devices that are awarded a 510k do not need pre-market approval by the FDA like non-510k devices.
Additionally, in November of last year the FDA acknowledged the concerns many people have with the 510k process and instituted a procedural change that allowed the 510k to continue to be awarded, but required the standard against which new devices are measured to be "objective performance criteria", a characteristically vague concession that side steps the core problem.
It's linked near the top of this article, but the same author also wrote a good article about uBiome last week: Insiders describe aggressive growth tactics at uBiome, the health start-up raided by the FBI last week