Richard,
I will discuss a little about the process for devices, but I'm not qualified to speak to drug approvals or practices so will leave to someone else.
As you correctly discern, device manufacturers are responsible for assessing the safety and performance of the materials used in their devices, including packaging. Generally this is done on a graduated scale based on degree of risk and amount of patient contact. For instance, it is probably obvious that more rigor is required for an implanted device than for one that touches a patient only briefly or not at all.
Initial screening and selection of raw materials is generally done by engineering teams based on the performance characteristics they need for a specific device. That said, there are a number of materials that are used in a lot of medical devices and those are often "first choices" because there is less risk of having a biocompatibility issue later.
Biocompatibility assessments and testing are the primary way materials are assessed for toxicity and safety. There are well established standards that must be met and testing generally is done on the finished devices. This is to account for any residual materials that may remain on the device after manufacturing, like, for instance, mold release. The test batteries vary depending on location and duration of contact, and include chemical characterization and an assessment of what can "leach" from the device.
From the supplier quality side, generally the manufacturer gives their requirements to the material supplier and the supplier certifies that the material meets those requirements. You may get access to basic chemical characteristics or a master file, or you might not. SOmetimes you simply verify their data and processes in supplier audits. Other times you may have incoming inspections that verify the chemical composition. Much depends on the use of the material and its regulatory pathway.
As for regulatory pathways, your guess is pretty good for PMA products. Generally in the device description section you describe the materials in detail. To the extent that information is confidential to the material supplier, they can file a "Master File" containing the information and grant you permission to reference it in your PMA.The PMA also presents all the biocompatibility testing data. FDA reviews these in the course of the PMA review.
However, in the 510(k) process the FDA generally would not review all this information. Generally there is a higher level summary of the materials and summaries of the biocopatibility testing. It is pretty unusual to reference a master file in a 510(k) that isn't a combination device - it happens but is not typical.
However, these devices, and 510(k) exempt devices, still are required by regulation to establish adequate safety of their devices and thus the related materials. The approach is usually the same, just that the data is not submitted. The data can be reviewed during FDA inspections.
This is a super high level summary of what can be a bit of a complex topic, but hopefully it was helpful.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 11-Oct-2018 08:06
From: Richard Kraska
Subject: Chemicals and polymers used in drugs and medical devices
My area of practice is in the food and food contact regulatory space. Occasionally clients ask me about chemicals used in drugs and medical devices. I presume that in the approval process, that chemical suppliers are asked to provide master files of information which FDA would review in the approval process. But what about drugs and devices that do not go through premarket approval. I presume that drug and device manufacturers are responsible for the safety of their product and they would review the purity information provided by suppliers. I can find no guidance on FDA's website on this issue. Any thoughts or guidance would be appreciated.
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