Hi Christopher,
There are several notices regarding pthalates such as DEHP on the FDA website. With regard to it's use in medical devices, could you let us know what the device is or class the device is and what the exposure is according to ISO 10993-1? This will help in determining the need and justification for testing.
Best,
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Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
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Original Message:
Sent: 06-Mar-2017 10:20
From: Christopher Smith
Subject: Phthalates
Hi, does anyone have experience with the use of phthalates within a medical device? I am looking to see if testing is required for leachability when the amount of phthalates is less than .01 percent. If not, where can I find the details and justification for not testing? Can you also provide guidance as to where I can find any information on phthalates and its use with medical devices.
Thanks
Christopher Smith, RAC
Sr. Director World Wide Regulatory, Compliance and Quality Systems
Chris.smith@symmetrysurgical.com
D 615.964.5392
M 508.965.5022
symmetrysurgical.com
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