I want to underscore something I said earlier: almost none of the organizations in this section are completely outside of FDA’s jurisdiction. They all have some, albeit perhaps minor, FDA responsibilities. Even distributors and retailers have to ensure their promotion remains consistent with the approved labeling, and their facilities appropriately safeguard the integrity of the products. Components suppliers, while technically exempt from the quality system regulations, often must nonetheless ensure that they are not selling adulterated components for use in medical equipment.
Over the last several years, I have read a dizzying array of corporate agreements that provide for various kinds of collaborations like these between companies. Some of them are fashioned as supply agreements, while others look like contract manufacturing agreements, and yet others look like intellectual property license agreements.
As a regulatory lawyer, when I read these agreements, often I’m asked to make a judgment as to who has the FDA regulatory responsibilities. And sometimes, honestly, it just isn’t clear. I’ve read agreements where all the specifications and promotional claims have to be mutually agreed upon between two parties. In other cases, one party maintains a general level of control over the specifications and claims, while the other party is able to exercise wide latitude within certain limits. In those cases, where it is genuinely unclear which party has the FDA responsibilities under the regulations, I believe FDA permits the parties to specify in the agreement who has those responsibilities, so long as that division is reasonable to resolve the gray area. So my advice: have your regulatory lawyer work closely with your corporate lawyer to make sure that your various collaboration agreements specify a reasonable – and your intended — division of labor on the regulatory compliance side.
Strategy 3: contract out the hard stuff. Even if your company markets what is admittedly a medical device and controls the specifications and the promotional claims so that your company is clearly regulated by FDA, that doesn’t mean your company itself must do the hard stuff. The regulatory work can generally be contracted out, even if the regulatory responsibility has to remain with the specification owner.
It probably won’t surprise anyone to know that there are whole industries designed to conduct various responsibilities of medical device specification owners in compliance with FDA requirements. For example, there are clinical research organizations that can do all of the clinical research, soup to nuts, and one of their main selling points invariably is that they take responsibility for the FDA compliance for that function. There are regulatory consultants who can quite ably prepare premarket submissions. There are contract manufacturers who specialize in producing product under FDA quality system requirements, and there are other consultants who can help bring the specification owners’ facilities up to code, so to speak. There are design organizations well-versed in conducting the design process in compliance with FDA design controls. Bottom line: if there’s some feature of FDA regulatory compliance that makes you nervous, there’s probably a whole industry out there quite willing to help you do it.
That said, it bears repeating that you can contract out the work but not the responsibility. If your organization is the one that controls the specifications and the labeling, your organization will bear ultimate responsibility for FDA compliance. As a practical matter, if you choose to contract out any of that work, it means you have the obligation to be duly diligent in selecting the right qualified firm to help you do the work, and providing reasonable oversight for the function. So the handoff isn’t complete.
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