If a product is not a medical device, but only a raw material or component to be used in the manufacture or assembly of one (807.65(a)), and therefore its offshore fabricator is exempt from registration and listing, how can / why should the initial importer list them without performing further manufacturing steps (which would make them more than just an "initial importer")?
The advent of PREDICT has caused considerable confusion, not least at FDA where such questions now need legal answers where before they could be left acceptably vague. I've had extensive discussions with FDA elements--the Dallas district office and the Office of Compliance, in particular--regarding this specific matter.
We've been shown an internal PREDICT-training Powerpoint that clearly states that the FDA country of origin may differ from the CBP country of origin. This is the crux of the confusion among kit packers, in particular.
Some manufacturers import fabricated medical-device-precursors in bulk nonsterile form, then market some of that import-volume to kit packers in bulk nonsterile form and the remainder of that import-volume in individually packed sterile form to end users. It's clear under existing rules that the latter share of total volume is CBP "made in USA", because (at least for our products) CBP has ruled that both individual-product packaging and sterilization are "substantial transformations". We've been told that FDA also regards the latter case as clearly FDA-made-in-USA, i.e. those products become legal medical devices at the US manufacturer. The legal question has been, what about the bulk non-sterile sales to kit packers?
The offshore supplier doesn't have any way of knowing that some percentage of total volume is going to be sold in bulk non-sterile form to kit packers.
Our understanding of the FDA determination in our circumstances, as separately explained to us by the Dallas district office and by Office of Compliance, is that the proper understanding in the case of sales of offshore-precursor-fabricated bulk nonsterile products to kit packers is:
1. The offshore-precursor-fabricator legally can be qualified per 21CFR 807.65(a), as long as they do not distribute to end users and are otherwise qualified, if a percentage of the products they sell to the US buyer are further transformed and if the US buyer is a registered device maker and lists the resulting devices.
2. In this scenario, a kit packer in effect is a contract sterilizer and packer of the bulk nonsterile devices they buy, and this provision of contract services to a legal US device manufacturer does not change the legal responsibility for those devices. Therefore--for purposes of this scenario only--the transformations that
physically occur at the kit packer are
legally occurring as if at the US device manufacturer. (Though of course the kit packer is legally responsible for those transformations as well.) The US device manufacturer thus is the point of
legal FDA-rules creation of (and regulatory responsibility for)
all the medical devices they sell, even though in the case of that percentage of total offshore-precursor-sourced volume that is sold bulk nonsterile the legal US device manufacturer has not
physically transformed the products themselves.
If this explanation is difficult to accept, sorry, it's the best I can do. I won't be offended if you contact FDA and get your own answers. My guess though is that they won't be willing to answer hypotheticals. The only reason they were willing to work with us, begrudgingly, is because we and several of our large kit-packer customers were specifically behind the legal eight-ball in regard to how to handle this.
