Strategy 2: avoid controlling the product specifications or the claims made. Most FDA requirements, including the need to obtain FDA clearance or approval, and the responsibility for reporting adverse experiences fall on the company that owns and controls the product specifications and the claims made. Because most of the risk of a medical device stems from its design and the claims made about it, whoever controls those two features has most of the FDA compliance responsibilities. So, if you don’t want those responsibilities, don’t own or control those two features of the device.
Some examples probably would help. In most cases, a contract manufacturer does not control the product specifications or the claims made about the product. That’s true even if the contract manufacturer produces finished product and drop ships it to the ultimate purchaser on behalf of the specification owner. In that case, FDA looks to the specification owner for compliance with most of the agency’s requirements, even if the specification owner never even touches the device.
Indeed, ownership of the product and the control of the specifications and labeling determine regulatory responsibility instead of who in fact engaged in the design process or wrote the label. Companies often ask a contract manufacturer to help with the design process, or enlist the services of an engineering firm. None of that matters. The only thing that matters is who, at the end of the day, owns the product and controls the specifications and the label for the product.
This control rule is also the basis for organizations such as distributors and retailers to pass regulatory responsibility up the chain of distribution to whichever entity controls the specifications and the labeling. Although distributors and retailers have limited FDA responsibilities, the responsibilities for seeking FDA clearance and ensuring the quality of the product remain with whoever controls the specifications and labeling.
Components suppliers similarly avoid much of the onerous elements of FDA regulation. If a company makes an article that is incorporated into a finished medical device, the maker of that component is not directly subject to FDA regulatory requirements for premarket clearance or even the quality system requirements. Instead, the finished device manufacturer is obliged to have in place supplier controls sufficient to ensure the quality of the components it uses. These controls might include, for example, periodic inspections of suppliers.
Another strategy is to supply finished medical devices to a firm that will co-package its own device with yours. From a regulatory standpoint, this is essentially the same as the component supplier scenario just discussed. Even though the article is a finished one, if it is bundled together with another product before it is sold to the end user, the company that does the bundling has responsibility for ensuring that each product in the bundle has the requisite regulatory compliance. Sometimes the supplier for the article to be bundled will undertake compliance with the FDA requirements itself, and sometimes the bundler takes that job. But because the bundler is considered to own the specifications of the bundle and whatever claims are made for the bundle, it generally has the ultimate regulatory responsibility.
Let’s take, for example, a common cell phone, hypothetically call it a mePhone. If the cell phone manufacturer makes no medical claims about it, the cell phone manufacturer will have no direct FDA responsibilities. But let’s say a blood glucose meter manufacturer claims, in promotional materials, “our meter will pair with the mePhone to down load data for analysis on our special app.” Arguably the blood glucose meter manufacturer has made the mePhone and the app into components of its medical device system. So the blood glucose meter manufacturer may, for example, either need to prove through a risk assessment that mePhones available in the market place will remain suitable for that intended use, or need to enter into an agreement with the mePhone maker such that the two companies, through cooperation and control, will ensure the future compatibility of the two devices. I’ve kept this simple but in real life these facts are usually much more complex.
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