Join partners Greg Levine and Josh Oyster from Ropes & Gray’s life sciences regulatory and compliance practice group for a special edition of Non-binding Guidance, a podcast series which focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, Greg and Josh discuss the publication of Ropes & Gray’s U.S. Medical Device Recalls Resource Manual, a reference tool to guide medical device companies considering, planning, or executing product recalls and other field actions.
Greg Levine: Hi, I’m Greg Levine, a partner in the life sciences regulatory and compliance practice group in Ropes & Gray’s Washington, D.C. office. I’m joined today by partner Josh Oyster for a special edition of our Non-binding Guidance podcast series which focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. The reason this episode is a special edition is that we are announcing the publication of our new U.S. Medical Device Recalls Resource Manual, which is a resource that we developed to guide companies considering, planning, or executing medical device recalls and other field actions.
Let’s dive in. To start with the most obvious question—What is the manual? The U.S. Medical Device Recalls Resource Manual is a reference tool for medical device companies. It begins with a preface and handy visual aids describing key recall considerations, including how to make risk‑based recall decisions, how to be recall-ready, and how to prepare recall communications. The remainder of the nearly 600-page manual is a compilation of relevant statutory provisions and Food & Drug Administration (FDA) regulations, guidance documents, manuals, and training materials related to medical device recalls. Many of these FDA statements are hard to find, and as far as I’m aware, they’ve never previously been compiled in one place. This is what the manual does: it consolidates these key sources of FDA guidance in one spot for easy reference.
Josh, why don’t you explain what led us to create this manual and the value that we think device companies will be able to get out of it?
Josh Oyster: Sure. Thanks, Greg. We were routinely counseling clients on medical device recall issues and encountering a lot of common questions like, “Do we need to recall this product?” or “How do we communicate about this recall?” A lot of our device company clients were also struggling with identifying and understanding everything that FDA has said about recalls so that they could make informed decisions in this area. As you mentioned, the information from FDA is, in some cases, all over the place and not always easy to digest. We conceived the manual as a way to help answer these questions and help device companies navigate recall issues.
Greg Levine: Before we go on, let’s make sure that our listeners understand how to get a copy of the manual. If you’re interested in the manual, please reach out by email to firstname.lastname@example.org.
Now, Josh, why don’t we turn to what some of the common issues are that we see companies facing with medical device recalls and that we discuss in the preface to the manual.
Josh Oyster: Sure, happy to jump in here. Some of the common questions we encounter all the time include, “Do I need to do a recall in the first place? Is this action that I’m planning in the field considered a recall, as FDA defines that term? Might this field action be something that FDA might consider a device enhancement? How do I assess the health hazard associated with this issue? How do I communicate to customers about the recall? How do I communicate to FDA about the recall? What am I required to communicate to FDA about the recall?” These are all the sorts of common questions that device companies have to navigate when considering whether to initiate a product recall. One of the most interesting ones that I find is really the first one that I mentioned, which is, “Do we need to do the recall in the first place?” For as obvious a question as it is, it’s not always a clear answer, except in the extraordinarily rare case when FDA mandates a recall. There’s no specific U.S. law or regulation that tells manufacturers or distributors exactly when they must recall a device, but once a manufacturer knows that a device it sold or distributed is, in some respect, defective or otherwise in violation of the law, it has to grapple with the decision of whether to leave that product on the market in its current form.
Greg Levine: This is really one of the most important concepts for people to understand, which is that the law doesn’t tell you what to do; it’s a judgment call. Yet you can be faulted for not doing the right thing. We discuss—and I think we give some pretty useful guidance and good guidance into—the kind of considerations that a company needs to take into account in making this kind of judgment. I think the preface to the manual has a lot of long and hard-earned wisdom on these issues that hopefully will be very useful to clients.
Josh Oyster: One of the other things I find interesting with device recalls is figuring out what to communicate to FDA and when. Under FDA regulations at 21 C.F.R. Part 806, device manufacturers must generally report recalls to FDA within 10 days of their initiation. There’s some limits and caveats to that. Device companies are not technically required to notify FDA of a potential recall before it’s initiated, but many device companies, as a matter of practice, do provide such advanced notice in order to get FDA’s input on their proposed recall strategy and communications. As with the question of whether you do a recall in the first place, deciding whether to notify FDA in advance of a recall is a judgment call.
Greg Levine: Yes, those and other topics that are really challenging to handle are discussed in our preface to the manual. We also provide some recommendations on recall readiness and a recall checklist. One other thing I want to point out here is that we designed this manual to be U.S.‑specific, but we know that because of the recalls that we handle with our clients all the time, more often than not, recalls are global in nature. Or at least, one needs to consider whether a recall should be global in nature or what countries it needs to cover, and so on. We were already at 600 pages with just the U.S. resources, so we didn’t try to cover the whole world, but we discuss a little bit that these kinds of global considerations need to be taken into account as well. One of the issues that we see pretty frequently is, let’s say, it’s a U.S.-based company with global distribution. They decide to undertake a recall in the United States but not necessarily in every other country around the world, and then you start to get inquiries from global regulators in other countries such as, “Why isn’t this same device being recalled in our country?” One needs to have a very legitimate and robust justification if that’s the kind of action you’re going to take.
Josh Oyster: I’m glad you mentioned the global implications in the 600-page manual. We’ll have to save the global resources for volume two of the manual. We’ll have to wait for the sequel on that.
Greg Levine: Yes, this took a while to put together, but maybe someday we’ll do the international version.
Josh Oyster: Switching back to our U.S.-focused manual, we do hope, again, that this will be a useful resource for device companies considering recall-related issues. It’s worth mentioning that there are guidances included in the manual for a number of the topics we’ve mentioned today, including FDA’s guidance on factors to consider regarding benefit and risk in medical device product availability, compliance and enforcement decisions, FDA’s guidance on distinguishing medical device recalls from medical device enhancements, and various other guidances and manuals from FDA on these issues.
Greg Levine: Thanks, Josh. That’s all the time we’re going to take up for today. We just wanted to make our listeners aware that this manual is available, and we thank you for tuning in.
As we mentioned, if you’d like to receive a manual, you can email email@example.com. Then, more generally, if you’d like information about our life sciences regulatory and compliance practice, you can visit our practice page at www.ropesgray.com. You can listen to Non-binding Guidance and other RopesTalk podcasts through our podcast newsroom on our website, or you can subscribe wherever you listen to podcasts, including on Apple, Google, and Spotify.
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