Julie
I too am unaware of any materials that are considered "approved" by FDA. The closest I've seen are what I would consider guidelines, such as reg. nr. 872.3710, which list specific metallic alloy classes (but not actual alloys) for use in dental crown.
That being said, vendors of metallic alloys and plastics will often use the term "medical grade" to describe a version of the material in question. This is not a well-defined term. For polymers it usually it means that there are no additives which are known to be problematic for biocompatibility. For metals, it usually means that they are on the list of alloys specified by ASTM in Book 13.01.
ASTM F75 Cast Cobalt-Chromium-Molybdenum Alloy for Surgical Implant Applications
ASTM F961 Cobalt-Nickel-Chromium-Molybdenum Alloy Forgings for Surgical Implant Applications
ASTM F799 Thermomechanically Processed Cobalt-Chromium-Molybdenum Alloy for Surgical Implants
ASTM F562 Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy for Surgical Implant Applications
ASTM F1058 Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy for Surgical Implant Applications
ASTM F563 Wrought Cobalt-Nickel-Chromium-Molybdenum-Tungsten-Iron Alloy for Surgical Implant Applications
ASTM F1108 Ti6Al4V Alloy Castings for Surgical Implant Applications
ASTM F620 Titanium 6Al-4V ELI Forgings for Surgical Implant Applications
ASTM F67 Unalloyed Titanium for Surgical Implant Applications
ASTM F1341 Unalloyed Titanium Wire for Surgical Implant Applications
ASTM F136 Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications
ASTM F1472 Wrought Titanium 6Al-4V Alloy for Surgical Implant Applications
ASTM F1295 Wrought Titanium 6 Aluminum-7 Niobium Alloy for Surgical Implant Applications
ASTM F138 Stainless Steel Bar and Wire for Surgical Implants (Special Quality)
ASTM F139 Stainless Steel Sheet and Strip for Surgical Implants (Special Quality)
ASTM F899 Stainless Steel Billet, Bar and Wire for Surgical Instruments
ASTM F745 Stainless Steel for Cast and Solution Annealed Surgical Implant Applications
ASTM F621 Stainless Steel Forgings Surgical Implants
In addition there is a specification for tantalum
ASTM F560 Unalloyed Tantalum for Surgical Implant Applications
For cardiovascular devices, shape memory alloys based on nickel-titanium or "Nitinol" are widely used.
ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2633 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
Eager potential 510(k) applicants often interpret the vague term "medical grade" to mean "no biocompatibility studies needed." In practice what I have seen is that relying on materials with a history in the application is route to clearance with the fewest speed bumps..
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Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
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Original Message:
Sent: 25-Jan-2017 10:44
From: Julie Omohundro
Subject: "FDA-Approved" Materials?
What are the "good" definitions of this term that you have encountered?
By "good" I mean definitions that are somewhere in the ballpark of actual FDA approval of the material, as opposed to not-so-good definitions that sometimes underlie its use, such as "a material that has been used in some other medical devices that FDA approved once upon a time for some intended use, and therefore we can be confident that FDA will accept it as suitable for use in any medical device for any intended use today."
I have heard there is a list of materials somewhere that some people refer to as "FDA-approved," but I haven't seen this list myself.
I have also heard that there are device-specific guidances (e.g., a special controls guidance) that identify "approved' materials for specific devices, but once again, I haven't seen any of these guidance myself.
Any light shed will be much appreciated.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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