Re:FDA Warning Letter to 23andMe
by ska on Monday November 25, 2013 @02:07PM
(#6796161)
(expanding a little on nknighthb's comments):
The primary path to approval to market for a new device or drug is the PMA (pre market approval). This is fairly extensive an costly for the company (e.g. clinical trials). A 510(k) filing allows you to take a short cut by identifying a "predicate device" that is "substantially equivalent". In other words you are saying "we do the same as X but we [also do Y/do this differently/etc.]". At least, you are claiming this for the scope of your "indications for use" (which are the only uses you can market your device for).
This doesn't let you off the hook entirely at all. You still need to demonstrate safety and efficacy, perform risk analysis, follow standard manufacturing and product development methodologies (e.g. ISO13485, IEC60601, etc. ), but it is a lot faster and less involved than a PMA.
If you don't use one of these accelerated paths, you'll need a PMA before you can market your product in the US.
The key issue here is that 23andme has filed one or more 510(k)'s, but have failed to support them properly.
The primary path to approval to market for a new device or drug is the PMA (pre market approval). This is fairly extensive an costly for the company (e.g. clinical trials). A 510(k) filing allows you to take a short cut by identifying a "predicate device" that is "substantially equivalent". In other words you are saying "we do the same as X but we [also do Y/do this differently/etc.]". At least, you are claiming this for the scope of your "indications for use" (which are the only uses you can market your device for).
This doesn't let you off the hook entirely at all. You still need to demonstrate safety and efficacy, perform risk analysis, follow standard manufacturing and product development methodologies (e.g. ISO13485, IEC60601, etc. ), but it is a lot faster and less involved than a PMA.
If you don't use one of these accelerated paths, you'll need a PMA before you can market your product in the US.
The key issue here is that 23andme has filed one or more 510(k)'s, but have failed to support them properly.