9 Online FDA Resources For Prospective Medical Device Manufacturers

The FDA is  not only the regulating agency  for this market, it is also a storehouse of information. FDA_general

Today’s post is short on text, but packed with authoritative links to the materials available on the FDA website.

  1. 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.
  2. 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.
  3. Current Good Manufacturing Practices (cGMP) Rule links (on FDA website).
  4. An easier to read and understand   Introduction Presentation.
  5. The October 7 1996 Federal Register (as .pdf).
  6. Is your product a device?
  7. Definition of a device  see section (h) here.
  8. Class II  medical device exemptions 510(k).
  9. Class III device.

What informative links or references have you identified to help you navigate the medical device regulations?

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