Comment from Macleods Pharmaceuticals Limited, India.

Guidance recommends evaluation using three different materials of construction for nasogastric (NG) tubes, including PVC. However, We wish to notify the Agency that PVC MOC remains unavailable to access for PVC NG /G-Tube in future due to safety concern as Leaching of plasticizers (DEHP, phthalates) - Traditional medical-grade PVC requires plasticizers to stay flexible. These can leach out over time into the body or feed, raising toxicity and endocrine-disruption concerns. We have attached herewith a Federal Register Notice on the use of PVC in medical devices for your reference.