Docket Management
Docket: 01D-0514 - Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Stephen Clavelle Date/Time 2002-01-08 09:16:44
Organization Huntleigh Healthcare
Category Company

Comments for FDA General
1. General Comments As a manufacturer of disposable medical equipment and with the advent of third party reprocessing, accurate labeling of reprocessed product is a major concern. In the unfortunate situation of an adverse event with a reprocessed item, the reprocessed item must be tracked back to the (re) manufacturer as opposed to the oem as has been the case prior to the new FDA guidance policy. How can the FDA regulate the new policy without proper labeling that holds the (re) manufacturer accountable in an adverse event situation? If the FDA's goal is to protect the public through this new guidance policy then they must enforce the same labeling requirements of oem's with the third party reprocessors that identify them as the (re) manufacturer of that product. MDR's will never be accurate without labeling requirements strictly enforced. The (re) manufactured product must cleary identify the third party reprocessor as the (re) manufacturer.

EC -2