If the plastic you are using is in intimate contact with the patient, such as tubing used to transport blood, then your risk analysis will contain a toxic safety hazard. In that case, you cannot possibly meet FDA acceptable toxicity standards such as ISO 10993-x because you will have no documentable control over the plastic's composition - which may then lead to the hazard.
If the plastic is not in intimate contact with the patient, such as an electronics housing, then a toxic safety hazard probably does not exist and the only potential FDA requirement for the plastic may exist in either an FDA Performance Standard that is specific to the particular medical device you are manufacturing or in a related FDA Guidance document (unlikely). The FDA does not have performance standards for all medical devices, only a few. You can call the FDA Division of Small Manufacturer's Assistance to see if anything they know of is relevant to your medical device: 1-800-638-2041, or you can look through their web site at http://www.fda.gov/cdrh/dsma/dsmamain.html#contents. The main CDRH web site is at http://www.fda.gov/cdrh/index.html. These are my opinions, not those of my employer. Good luck Tom Brose [email protected] > -----Original Message----- > From: Darrell Locke (MSMail) [SMTP:[email protected]] > Sent: Wednesday, January 07, 1998 3:49 PM > To: '[email protected]' > Subject: Regrind Used in Plastics for Medical Products > > Fellow Members, > > I have heard there is an FDA requirement that NO regrind is allowed > for > plastics used on medical > products because of concerns of contamination. Can anyone verify > that > this is true? > > Thanks for your help > > Darrell Locke > Compliance Engineer > Advanced Input Devices
