Hello Sheemah,
This was traditional managed by EPA which has now moved to individual state or local requirements
https://www.epa.gov/rcra/medical-waste; there is really no federal requirement. You also have OSHA which regulates "sharps" disposal and CDC which has guidelines for handling infectious materials
https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html. Also individual hospitals or laboratories often have their own requirements (policies or procedures) for waste disposal including IVD products. From a medical device/IVD labelling perspective, often companies put the general statement of "dispose of medical waste according to local or national regulations" - which would be specific to the type of device. Depending on the type of waste this can also be handled differently from just going in land-fill to needing incineration. As example, working in Massachusetts when we had returned devices and blood products used in the lab, these were all accumulated in a central location which we had a third-party collect the boxes and take to an incinerator. From a user/customer perspective, again this often depends on the institution or the local regulations.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 05-Aug-2021 15:03
From: Sheemah Kazi
Subject: Disposal of IVD's
Hi Everyone,
Are there any specific federal labeling requirements for disposal of IVD's in the US?
I tried looking up for any guidance documents but could not find any.
Any insights will be helpful.
Thanks,
Sheemah
------------------------------
Sheemah Kazi
QA/RA coordinator
Concord CA
United States
------------------------------