Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

PVC/DEHP

This article was originally published in The Gray Sheet

Executive Summary

CDRH issues 1"Dear Colleague" letter to health providers July 12 listing 10 procedures posing the highest risk of exposure to di(2-ethylhexyl)phthalate, a plasticizer added to polyvinyl chloride that may be harmful to male reproductive organs. The health notice is based on a safety assessment completed by the agency in September (2"The Gray Sheet" Sept. 10, 2001, p. 18). For some high-risk procedures, "PVC devices that do not contain DEHP can be substituted, or devices made of other materials (such as ethylene vinyl acetate (EVA), silicone, polyethylene or polyurethane) can be used," the notice advises...

You may also be interested in...



DEHP Study Prompts FDA To Consider Safety/Availability Of PVC Alternatives

FDA will examine the safety and availability of alternatives to devices containing the plasticizer di-2-ethylhexyl-phthalate (DEHP) before considering a risk management strategy.

US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising

US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT016866

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel