We thought you might be interested to learn that the FDA has completed its “Device/Not a Device” determination and concluded the handgun will be listed as a Class I Medical Device, exempt from 510(k) Pre-Market Notification in accordance with 21 CFR 890.5050 “Daily Activity Assist Device.”Hat Tip /.
We have now submitted an application to the CMS contractor Noridian for a DME (Durable Medical Equipment) Coding Verification in order to be assigned an HCPCS code. Once assigned , physicians will be able to prescribe the Palm Pistol for qualified patients who may seek reimbursement through Medicare or private health insurance companies.
Friday, December 05, 2008
Doctors able to prescribe handgun on prescription
If the assault rifle with the chainsaw bayonet wasn't too out there for you, how about a new determination by the US Food and Drug Administration that classifies a gun as a medical device, available on prescription?
