Suppose that you have a company that makes plastic syringes out of plastic A were to decide "Hey Plastic B is much cheaper lets use that instead". Would the product classification change? Would there be a need for a PMA assuming this new Plastic B was never used before? Or could the company just classify it as a class 2 justifying that there are similar products on the market that perform the same task?
For the case of the syringe, it would depend on the interaction with the body. I think that would have rather large implications and would dictate the various routes that may have to be pursued. For the syringe, the plastic portion would not come in direct contact with the body per se so I do not believe the product would have to be reclassified as a result.That is if we are going from plastic A to B but both have been used in the past. In regards to using a completely new plastic material that has not be used before, there would have to be extensive bio-compatibility studies performed depending on the interaction the material have with the human body. There can be equivalency studies performed to show how plastic A for example has similar characteristics to the new plastic to keep the classification as class II device. However, if the composition of the plastic itself is completely novel then I believe one would have to the PMA route since there would be no precedent in the past. There would have to be extensive testing performed from probably an animal study to clinical study route.
Hello,
For any case that require a material change, even if it is already in market. It has to be notified to the FDA. It is clearly mentioned in the FDA guidance document . A change or modification in the device that could significantly affect the safety or effectiveness of the device should require a new premarket notification. Changes that are not intended to significantly affect the safety or effectiveness of the device,however, should still be evaluated to determine whether the change could significantly affect device safety or effectiveness.
Please refer to the FDA document for more clear information when a material is changed how the product classification changes.
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf
Whenever there is a change made to an existing device first thing a company should do is check whether the change affect safety, efficacy and performance of the device. This information can be documented in a Letter to file (document that used for internal record) or a PMA/510K based on device classification and regulatory logic. In the example of change in material if the material is from an approved list by the FDA than a simple letter to file will do and no FDA pathway is required but if the material is not on of the approved one than it needs to go through FDA pathway and change in material wont affect class of device. But once everything is approved it needs to be updated on device label.
Changing the material of the product can definitely change how the project is classified. Even though the syringe designs may have the same design specifications causing one to say they are similar products, the difference in material really makes these two separate products. The different materials will react differently with whatever the syringe contains. This idea is somewhat similar to the scenario of the Tooth Regeneration Scaffold Project from last week’s mini sim. In that case, the drug already existed in the market. However, with this new application, the safety of the device is being called into question forcing the clinical trials the come with being a class 3 device. Changing the material of the syringe calls into question the safety of the device in the same manner.
Any major changes, in this case material composition changes, needs to be reported to the FDA. In the event that it is a novel material or a novel use of the material, in vivo studies will have to be done to verify and validate its performance because the material plays a huge role in the performance, safety, and function of a device. By changing the material, the device is no longer the same device and may have to go through 510(k) that requires clinical trials because of the unknown risks associated with the new material or even need to go through a PMA. In either case an IDE will most likely be required along with animal models to prove the similarity of performance or that the new material does not pose a greater risk than the original material used.
While I don’t know the ins and outs of the FDA, should the risk associated with Plastic B be statistically significantly greater than Plastic A, the chances of the product being approved will be much slimmer unless the factor of pricing is that significant of a factor when considering patients, where in the case of a syringe it is not.
The compatibility of Plastic B with all the chemicals, drugs, and fluids conventionally used with that type of syringe will also need to be tested. From a company standpoint, the initial investment to get the new product will out weigh the gains for quite some time. If it takes 10 years to make back your initial investment, then even if your saving your losing. Further research should be done into the applications the material is being used for to see if they can make a product that they claim only works for specific tasks like drawing blood when laced with an anticoagulant and over the years slowly expand the claims through various projects. This will reduce the initial investment required and make it possible to avoid clinical trials since the plastic is not coming into contact with the body, and only validations on the materials compatibility with contents placed in it need to be done. Since testing has been done for certain applications already, the company can avoid the unnecessary cost of proving something that is already proven or need as strong evidence since they are corroborating what is already found.
I think that using a different material can definitely cause a change in the product classification of a product. The overall impact of the material being used depends on what the material being used is and whether or not it has been safely used in similar applications in the past. Introducing a new material for a device that interacts with the biological system that hasn't been used or proven safe in the application that the product is intended to be used in poses a risk that needs to be addressed and would likely make the device a higher class device to ensure that the risk associated with the new material is sufficiently tested.
In the case of the syringe, I think the decision to classify the device would come down to the fact that Plastic B has never been used as the material for a syringe, which would make it a higher risk device and possibly a class III device.
I agree with ial4 and appreciate sharing the guidance for market approval/submission when there is a change in a medical device. Depending on the risk from the change being made and the classification of the device determines whether a interim notification, a new 510(k) submission, or premarket approval (PMA) will be necessary. Either way, the FDA needs to be notified on the change. The risk assessment and the product change request being made will determine the regulatory submission lead time. So if changing the product's material will be cost effective to the legal manufacturer, but will increase the risk, decreasing the device's safety, then a new submission will need to be made to the FDA. In Guiding Principles (Section IV. Part 7) it discusses a significant change of a product from its preamendment device. In my opinion, the section highlights if the change is significant enough, it could potentially change the product's classification.
I agree with all the comments made here, and would like to add mah52's plastic syringe example that as plastic is chemically inert, use of a different grade plastic material would not require a PMA. Also the syringe wouldn't be coming in contact with the body, so there is no chance of occurrence of infection. Even if it did come in contact with the the body, plastic is biocompatible, so that wouldn't be a cause of concern either.
The classification should not and will not change when the material is changed. Of course a PMA will be needed will filling out the paperwork but even if it is a new material, the class will not differ. This is because there is a similar product and it does similar things. Before using the material, the material being created will have to go through FDA and find out what class that is depending on how much risk it is to the user.
From my experince with Innodisk, A lot of our customers from Medical sector tent to request a locked bill of materials after the FDA approval. Eventhough simillar components will do the same functionality. but they have different tolerence. non of the componants is accurate 100%. So, they react differently with different systems and can cause a compatitbilty issues. Also, Some project it required to go through FDA approval, which most customer try to avoid to same time if they can. FDA approval can take several monthes and lock BOM is one of the first option customer tent to look for it when it come to very customized solutions.
