jmdrake
05-25-2013, 05:18 AM
http://www.ibtimes.co.uk/tech-science-videos/2753/bionic-arms-chinese-farmer-home-built-tech-business.html
I added the "and sells" part to the title because I think it's the most important part. Something tells me that if he tried to do that in America, build and sell prosthesis without prior FDA approval, that he'd get in trouble here in the U.S.S.A. Not to mention potential product liability.. Yay freedumb!
Edit: I didn't have to look hard to find out that indeed this farmer would have been regulated out of business in Amerika.
http://openprosthetics.wikispot.org/Federal_Regulation_of_Prostheses
In the United States, most upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [WWW]classifies medical devices as Class I, II or III. While most Class I devices are subject to the full set of [WWW]general controls, including that they be "manufactured under a [WWW]quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [WWW]prosthetic components and a [WWW]few other devices are exempt from these general requirements and subject only to [WWW]record keeping (21CFR820.180) and [WWW]complaint file (21CFR820.198) requirements, as stated in the [WWW]Code of Federal Regulations, Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [WWW]21CFR890.3420. This section states that these devices are exempt from premarket approval or [WWW]510(k) requirements, except as provided in [WWW]21CFR890.9, which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. As [WWW]this document from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included.
I added the "and sells" part to the title because I think it's the most important part. Something tells me that if he tried to do that in America, build and sell prosthesis without prior FDA approval, that he'd get in trouble here in the U.S.S.A. Not to mention potential product liability.. Yay freedumb!
Edit: I didn't have to look hard to find out that indeed this farmer would have been regulated out of business in Amerika.
http://openprosthetics.wikispot.org/Federal_Regulation_of_Prostheses
In the United States, most upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [WWW]classifies medical devices as Class I, II or III. While most Class I devices are subject to the full set of [WWW]general controls, including that they be "manufactured under a [WWW]quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [WWW]prosthetic components and a [WWW]few other devices are exempt from these general requirements and subject only to [WWW]record keeping (21CFR820.180) and [WWW]complaint file (21CFR820.198) requirements, as stated in the [WWW]Code of Federal Regulations, Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [WWW]21CFR890.3420. This section states that these devices are exempt from premarket approval or [WWW]510(k) requirements, except as provided in [WWW]21CFR890.9, which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. As [WWW]this document from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included.