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Related Topic Tags
fda (food and drug administration), material specifications, medical devices (general), polyethylene, materials (general)
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  #1  
Old 9th October 2011, 11:48 PM
Arnthor Arnthor is offline
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Please Help! US FDA Approved Materials (which can be used for Medical Devices) List?

Dear all,

Does US FDA have a database for approved list of materials which can be used for medical device?

When a supplier claim their product is medical grade (eg, Polyethylene), what is US FDA definition of medical grade?

Any insight is appreciated!

Best regards,

Arnthor

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Old 10th October 2011, 01:54 AM
MIREGMGR MIREGMGR is offline
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Re: US FDA Approved material list?

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In Reply to Parent Post by Arnthor View Post

Does US FDA have a database for approved list of materials which can be used for medical device?
Not as such. However, US FDA does Recognize a number of material-related Standards, each of which defines a particular grade, composition or formulation of a material. See http://www.fda.gov/MedicalDevices/De...ds/default.htm.

If you use such a material in your device, US FDA will accept that material as suitable from a formulation perspective, subject to any special conditions that the Standard defines. You may however have to show that your use of that material is suitable i.e. if the Standard recognizes uses A, B and C but your device uses the material in novel manner D, that will require evidence of suitability. See http://www.fda.gov/MedicalDevices/De.../ucm142706.htm and http://www.fda.gov/MedicalDevices/De.../ucm077274.htm.

Quote:
When a supplier claim their product is medical grade (eg, Polyethylene), what is US FDA definition of medical grade?
There is no such US FDA definition. Any material can be used in a medical device if it's safe and effective in the application.

Probably what the vendor means is either that the material conforms to a Standard that is Recognized by US FDA, or that the material has been subjected to an appropriate series of ISO 10993 biocompatibility tests by somebody--its maker, the vendor, or someone else--and found to be biocompatible.

In the former case, presumably the material willl be supported with a certification of conformance, plus perhaps some evidence such as a third party lab test. In the latter case, a statement of conformance is meaningless unless a copy of the third party lab test is provided as evidence that you can then provide to US FDA in conjunction with a clearance process for your device.

A warning: if you run into a material vendor that claims medical device suitability based on USP or "Class VI", watch out. FDA split medical device materials qualification from pharmaceutical-packaging materials qualification as of 1995. Anyone still using that system obviously hasn't paid any attention to materials qualification in at least sixteen years.
Thank You to MIREGMGR for your informative Post and/or Attachment!
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Old 10th October 2011, 08:45 PM
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Re: US FDA Approved material list?

It is okay to say that if the material pass ISO 10993 biocomp tests, it can be used as a material for medical device?

Is there any extra requirement beside ISO 10993-4 -"Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood" testing if I am refering to blood contact component of the device.
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Old 10th October 2011, 11:21 PM
MIREGMGR MIREGMGR is offline
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Re: US FDA Approved material list?

Quote:
In Reply to Parent Post by Arnthor View Post

It is okay to say that if the material pass ISO 10993 biocomp tests, it can be used as a material for medical device?
Biocompatibility of patient contact materials and therefore the resulting device is a necessary, but not a solely sufficient, requirement for a patient contact device.

The fundamental requirement is that, whatever materials are used, the resulting device must be safe and effective.

If a material conforms to a Recognized Consensus Standard and is used in a manner that is consistent with that standard, you don't have to separately prove that that material is suitable.

Other than by conformance to a Recognized Consensus Standard, there is no simple basis for a statement that a material is acceptable for all medical device uses.

Quote:
Is there any extra requirement beside ISO 10993-4 -"Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood" testing if I am refering to blood contact component of the device.
If a device is of a well established type, usually FDA will require only the tests indicated for the intended use in guidance G95-1 http://www.fda.gov/MedicalDevices/De.../ucm080735.htm.

If a device presents novel issues regarding biocompatibility, FDA may require additional qualifications.
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