| Comment Record|
Mrs. Gwen Welty ||
2002-12-05 09:53:47 |
Alcon Research, Ltd. |
| Comments for FDA General |
1. General Comments
Dear Sir or Madam:
On September 6, 2002 in the Federal Register, FDA requested comments and suggestions on the draft guidance entitled, “Medical Devices Made With Polyvinylchloride Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA.” Alcon Research, Ltd. is respectfully submitting the following comments.
The draft guidance outlines the types of medical devices that may be of concern with regards to DEHP exposure. One of the medical devices listed is Intravascular (IV) tubing and catheters/cannulae used in IV administration. It is Alcon’s opinion that in this reference, IV sets should apply strictly to intravenous applications only. The use of IV tubing in the case of administering drugs or irrigation solutions in a non-venous application should not be considered of concern since significant exposure to DEHP does not occur.
The draft guidance document should better quantify exposure times to DEHP and exempt short-term exposure devices from the labeling requirements. As with many ophthalmic surgical procedures, patient exposure time to devices containing DEHP is minimal. It is Alcon’s position that since significant human exposure to the chemical does not occur in such circumstances, devices of this nature should be exempt from the requirement to revise labeling to state that the device contains DEHP.
Alcon appreciates the opportunity to provide these written comments in anticipation of future direction to regulated industry on this matter.
Please contact me should you have any questions regarding these comments at (817) 551-4774.
Regulatory Affairs Analyst III
Alcon Research, Ltd.