> Unlike drugs, each medical device has to be vetted by the FDA. Generic drugs can get quicker to market just by showing that they're equivalent to the already

> Unlike drugs, each medical device has to be vetted by the FDA. Generic drugs can get quicker to market just by showing that they're equivalent to the already approved drug. Devices can't do that. That is incorrect -- devices can do that. Devices shown to be equivalent to an existing device can be put on the market with minimal regulatory overhead. The form to submit to the FDA for an equivalent device is a 510k Premarket Notification. Details are here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc... This is what an acceptance letter from the FDA looks like for a substantially equivalent device: http://www.texasbiogene.com/upload/content/file/TBGFDAapproval.pdf http://www.texasbiogene.com/upload/content/file/TBGFDAapprov...