Julie Omohundro FDA doesn't approve materials. It approves finished medical devices. The fact FDA approved a medical product made of a particular material doesn't mean it will approve another medical device made of the same material. However, you would normally put materials used to make a device very similar to yours, especially in intended use, high on your list of materials to consider for use in your device.

If you are hoping to clear the device via the 510(k) process, you will also want to keep in mind that a difference between the materials used in your device and your claimed predicate may get scrutiny from FDA as a difference in technological characteristics that is could "raise new questions of safety and effectiveness."

Clarisa Tate I agree with Julie here. Furthermore, how the materials are put together, assembled, melted/soldered, manufactured, etc. can affect its biocompatibility (even strength, etc.). This is why there's a need to a test again even if the materials are the same if the special/critical manufacturing processes are different between similar products.

Elizabeth suggest you talk to a biocompatibility test house such as Wuxi or Nelson or look at the material in your predicate device.

Courtland Imel Elizabeth,
I think I understand what you are asking. The responses above are on target. I’ll suggest looking at USP Class V and Class VI materials, again depending on your device. You may also look at aluminum. You may also look at titanium rods inside plastic. On biocompatibility, I’ll add Geneva, NAMSA, and Toxikon. I hope this helps. Good luck.

Elizabeth, in my past I’ve dealt with this issue. While I agree with the other answers, my perspective is to look at the materials that have a Master File on file with the FDA. as I remember these list raw materials that have past biocompatibility testing. I think of this as a screening step; “at least there is a chance my finished device, with all its particular manufacturing processes, can be biocompatible without performing every biocompatibility test”.

Hope this helps

Elizabeth Doyle Rodger, that's exactly what I'm trying to find. Do you know where exactly to find materials with Master Files? Or how to search for them? I'm mostly getting results for drugs, not for materials.

Thank you everyone else for your answers thus far. I'm going to clarify my question.

Look for materials that have a Master file with the agency and if you want a lab that knows what they are doing call Exponent in Philly! Brilliant minds work their and connected to Drexel University! Another place is Analytical Answers in Woburn, MA

Andy Carter Master Files are not publicly available files and the owner of the file has to give the FDA permission to access the information when they are reviewing a submission. It is a way of companies providing confidential information to the FDA for them to review when one of their customers is filing for a device using that material. It is not information that anyone can use. The information in the files is also not reviewed or "pre-approved" by the FDA.

Hello Elizabeth. If you are looking for a polymer I suggest you check Solvay’s portofolio. They have MAF in place for a variety of polymers. Please contact me directly if you need contact information.

Have you considered metal powder injection molding?
It's a similar process to injection molding that produces a sintered metal part.
Advantage being the process is well studied for use with titanium and life critical parts (implants) have already been produced.
There's a good introductory article on it available on open access if you're interested. Has graphs of tensile strength and discussion of fatigue.
http://www.mdpi.com/1996-1944/6/8/3641/pdf

Hey Elizabeth... the answer also depends on the end use of the product.

For dental - Titanium alloys, Cobalt Chrome, Zirconia ceramics, Gold, and Bioglass have been used and generally accepted as biocompatible

Orthopedic - Titanium alloys, Cobalt Chrome, Stainless Steel, Alumina, some Polyethylene, and PEEK material

Cardio - Titanium alloys, Nitinol, Gold

But you also have a host of biomaterials, scaffolds, xenographic or allographic materials, combination products, synthetic and natural materials and applications i didn't mention (contact lense, neurological and audio implants...etc)

If you define the application, it will be easier to get a master list of materials that have a track record of biocompatibility for that end use.

Hi Elizabeth, I’m a polymer scientist with experience in materials processing and properties for orthopedic devices. At Lucideon, we also perform biocompatibility testing, test method validation and performance testing for FDA submissions. Please connect if you would like to discuss further.

Anastasia Tas Elizabeth, a different application needs different materials. You can use table 1 from EN 10993-1 standard to see the nature of body contact, duration etc. Most of the implants need the expanded list of testing according to 10993, initial material biocompatibility is important. Keep in mind that manufacturing processes and even sterilization could affect it. Titanium, PEEK, ceramics and stainless steel are the most common for orthopedic, trauma and dental implants.
for 3D printing, there are such materials as GelMa, collagen, gelatin...

The question you need to answer is: What materials (metals or polymers) will fulfill the strength properties of titanium in my application? Once you have answered that you can search for USP Class VI polymers as substitutes. The existence of a Master File does not always resolve the issue, in most cases the resin manufacturers sterilize the resin in one way for biocompatibility testing, and you might be doing it in another way requiring you to do further testing. The manufacturer is responsible for establishing biocompatibility for the desired / specific indication.

Marc Slabbert Hi agree with both Anastasia and Umit your question is not a list but a analysis of materials vs properties vs biocompatibility & FDA approval. I am involved in Post Graduate Research into Implants and am a Supervisor in Biomed Engineering feel free to chat to me re Titanium Implants and alternatives the current move is towards Ceramics however other materials are also being utilised strangely not all have Material properties of Tinanium such as strength but are being used in very novel ways PEEK is one of these examples

hi , SABIC has a list of APPROVED MATERIALS specially created for medical applications and they are all injection mouldable.. pls check sabic website

Julie Omohundro Suresh, approved by whom?

Hi Elizabeth,
For US FDA, any device needs to have it's biocompatibility validated (justified,) even if the material has been used before by your company. It can be really tricky to establish the existence of a "predicate" from another manufacturer.
For an implantable device, the biocompatibility evaluation will have to consider "physical characterisation" including surface topology, etc. in addition to chemistry.
Also, It is not very realistic to think one can just "drop" a new material into a device. the only material that has the same properties as Titanium is: Titanium, and processed in the same way! The material, design, and processing all need to be considered in order to realise a device.
To get you started, as you mentioned injection moulding, I'd advise you consider PAI and PEEK, probably from Solvay in the first instance.

3M documents and markets their material data sheets & specifications very well. They would be a valuable resource to determine if a material is /isn't suitable for the application.

Alisa Buchman Approved materials are those which were filed through master-files to the FDA
The materials I know are: UHMWPE, Titanium 4-6, SS, Ceramic (Alumina Zirconia), PEEK, PI (MP-1), Tantalum

Dear Elizabeth,
There isn’t such a “List” that exist for Biocompatible material…wishful thinking. Each manufacture has the flexibility to choose the best material for the device to be able to perform and manufacture at a scale to generate revenues with due consideration to COGs, however the manufacturer has the responsibility to demonstrate the biocompatibility of not the materials used but the final finished product/ device. Simply put, manufacture should not just take “like for like” approach for the materials used but should consider the processes that the material undergoes during the product realisation and then evaluate the biocompatibility as per ISO 10993 which is a recognised consensus Standard by the FDA.
Please contact info.raqs@gmail.com for any further information.
Best of luck.
Dev

Hi, Elizabeth. Zeus works with a number of polymers that have predicate use in a wide array of implantable applications. We'd be happy to better understand your specific requirements and assist in identifying suitable materials with appropriate regulatory history and supporting biocompatibility data. Please reach out at your convenience.

Arthur Brandwood Alisa Buchman - a master file isn't a materials approval - it's just a mechanism for the material manufacturer to protect their IP by sharing confidential detail only with FDA and not with their device manufacturer customer.

They file with FDA a dossier of technical data (aka Master File), usually including physical and biological testing data. FDA will put it on the shelf unreviewed.

Then if a device manufacturer comes along with a submisson to FDA for a device using that material, they get a letter from the materials manufacturer granting permission for the FDA to review the master file data in support of the device application.

Materials manufacturers sometimes charge a (not insubstantial fee) for master file access - so recovering some of their costs in developing the data.

Hi Elizabeth,

You’ll need to do some homework, first make a list of all the properties of the currently used material and then split them into essential and desirable.

Once that’s done, you could approach specialist polymer companies such as RTP group, Covastro etc

Polymeric materials will contain a number of additives too and hence you’ll need chemical characterization as well as leachability information, ideally in the type of environment you wish to impart. Specialist company may advise tweaking their formulation effectively giving you a “designer material”.

Finally, you’ll need to carry out biocompatibility study and stability study on the finished product.

I hope this helps

Definitively PEEK. Potentially thermoplastic like POM depending on your application. No database in my knowledge except a list of recognize or forbidden color agents. Regards - stanislas

Hi Elizabeth,

To build upon Champa’s comment - I think her comment is spot on with making sure you understand the critical product requirements that the material needs to meet and use that to guide your selection. I would also look at Pubmed to perform searches to see what materials are being used in your device implant area. Although there may be an advantage of using a novel material with new properties in your design from a marketing standpoint you need to weigh that against the regulatory costs and time to get that approved. Finally, also make sure to choose your supplier carefully - the chemical purity and consistent supply of that material is key. I have seen issues where we switched suppliers of a material only to find an undesirable impurity during the assessment of the material that was not present from the previous supplier due to differences in the process contact materials.

Taking more time on the front end to properly evaluate the material is worth not having a problem downstream during Biocompatibility or Design Verification/Validation testing.

Hi Elizabeth. FDA approves devices, not materials. There is no database of FDA approved materials. According to FDA's guidance on biological evaluation, "The Agency makes a clearance or approval decision for a medical device as it is supplied in its final finished form. The Agency does not clear or approve individual materials that are used in the fabrication of medical devices."

Arthur Brandwood is correct. A master file only provides information to FDA. A device manufacturer references the master file in a marketing application with authorization from the material manufacturer. This process protects the IP of material manufacturer because the information is not revealed to the device manufacturer. Master files are not approved by FDA.

Suggestions for material and chemical characterization, in relation to using a material in a device and biocompatibility of the finished device, are provided in ISO 10993 and also outlined in another comment by Champa Patel.

Join medical device group with ASTM. They meet semiannual and have the FDA as a monitor and friend. Jon is a good guy.

Great summary James. Even within materials like Titanium, silicone, etc. there of different grades with some specifically made for medical device use. Your supplier will advise on that. And then after your manufacturing process (managing your supplier quality, exposure to your equipment and manufacturing environment and packaging, etc.) your device will ultimately need to pass biocompatibility testing per ISO 10993.

As noted in the 2016 FDA Guidance on their application of ISO 10993-1, FDA approved devices, they do not approve materials.

Lisa Olson Bill is correct in his assessment. You can start with the GRAS list, if you are looking for a starting point for choosing a material. But you will have to do complete characterization and testing for your intended use.

Alisa Buchman Don't forget our bio-compatible material - Polyimide (MP-1) by MMATECH. This material is in use in hip implants, trauma, dental and will be used in spinal, cardio and ENT. (www.mma-tech.com
Other materials are UHMWPE, Ceramic (Alumina), Stainless steal, Titanium, Tantalum and PEEK (or PEKK).

I recommend searching public FDA documents related to your target device type to get an idea of common materials and the regulatory burden if you pursue something more novel. I'd be happy to show you how to do this.