The FDA is not only the regulating agency for this market, it is also a storehouse of information.
Today’s post is short on text, but packed with authoritative links to the materials available on the FDA website.
- Small Business Guide to FDA This .pdf document was last updated on 10/7/2008 and provides contact information as well as an overview of the Federal Register / publication of proposed regulations process.
- Design Control Guidance for Medical Manufacturers Because design controls must apply to a wide variety of devices, the regulation establishes a framework that manufacturers must use when developing and implementing design controls.
- Current Good Manufacturing Practices (cGMP) Rule links (on FDA website).
- An easier to read and understand Introduction Presentation.
- The October 7 1996 Federal Register (as .pdf).
- Is your product a device?
- Definition of a device see section (h) here.
- Class II medical device exemptions 510(k).
- Class III device.