If you are going to evaluate whether the U.S. system for clearing new medical devices is fair to industry and protects the public, you really should focus first on the section 510(k) process.
That's because most new medical devices get cleared for marketing by the U.S. Food and Drug Administration via the section 510(k) process (named for its subsection in the Federal Food, Drug and Cosmetic Act), which is supposed to be a relatively quick and simple method to establish that the new device is “substantially equivalent” to another device that's already legally on the market. No expensive clinical trials, just a compilation of information from the manufacturer, which FDA looks over, all designed to allow new products to “piggy back” on what's already known about devices of that type.
In fact, in recent years, many categories of devices have been exempted even from having to file a 510(k), on the theory that the devices of that type are simple and safe enough.
Back in 2008, a U.S. Supreme Court decision about medical device preemption got all the headlines. That case dealt with preemption of injury cases against makers of medical devices that had gone through the full premarket approval process. But it is relatively rare that a manufacturer has to employ that expensive, laborious process. Life for most medical device packagers and makers centers on the 510(k) process.
But the simple 510(k) is not always so simple, it turns out. FDA sometimes wants to see clinical trials in support even of the 510(k) submission. Manufacturers are sometimes too creative for FDA's tastes in describing their hot, new device as “substantially equivalent” to a traditional model. Companies often complain about an allegedly simple and quick process being unpredictable and unequally implemented. Meanwhile, Congressional overseers and other critics think too many devices sail into the market without enough scrutiny by the FDA, with resulting safety risks.
So in August FDA burst forth with two highly anticipated reports—still in preliminary form—one about ways to “strengthen and clarify” the 510(k) program, and the other about how FDA uses science in its decision-making.
The first report recommends, for example, making a more predictable but still quick process to account for devices that are too novel for 510(k)s, but not risky enough to warrant full-blown premarket approval. They also want a better definition of those devices that are 510(k)-worthy, and yet would still require some clinical or manufacturing data to satisfy FDA. Right now, applicants are often unpleasantly surprised to learn FDA wants that information only after filing.
Ever seeking a balance between protecting the public health and speeding new, innovative products to market, the FDA says its “three key objectives” regarding its public health mission for devices are to “foster device innovation, create a more predictable regulatory environment, and enhance device safety.”
Industry no doubt welcomes any useful method to improve predictability in this sometimes baffling area, and the FDA gives you the chance to shape these reports. The preliminary reports have been formulated with substantial public input, and FDA has asked for further public input on these preliminary reports. If you think these recommendations would affect your business one way or another, this is a good opportunity to place some facts before the agency to help shape policy changes. To do so, see www.
fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm.
--By Eric Greenberg, Attorney-at-Law
That's because most new medical devices get cleared for marketing by the U.S. Food and Drug Administration via the section 510(k) process (named for its subsection in the Federal Food, Drug and Cosmetic Act), which is supposed to be a relatively quick and simple method to establish that the new device is “substantially equivalent” to another device that's already legally on the market. No expensive clinical trials, just a compilation of information from the manufacturer, which FDA looks over, all designed to allow new products to “piggy back” on what's already known about devices of that type.
In fact, in recent years, many categories of devices have been exempted even from having to file a 510(k), on the theory that the devices of that type are simple and safe enough.
Back in 2008, a U.S. Supreme Court decision about medical device preemption got all the headlines. That case dealt with preemption of injury cases against makers of medical devices that had gone through the full premarket approval process. But it is relatively rare that a manufacturer has to employ that expensive, laborious process. Life for most medical device packagers and makers centers on the 510(k) process.
But the simple 510(k) is not always so simple, it turns out. FDA sometimes wants to see clinical trials in support even of the 510(k) submission. Manufacturers are sometimes too creative for FDA's tastes in describing their hot, new device as “substantially equivalent” to a traditional model. Companies often complain about an allegedly simple and quick process being unpredictable and unequally implemented. Meanwhile, Congressional overseers and other critics think too many devices sail into the market without enough scrutiny by the FDA, with resulting safety risks.
So in August FDA burst forth with two highly anticipated reports—still in preliminary form—one about ways to “strengthen and clarify” the 510(k) program, and the other about how FDA uses science in its decision-making.
The first report recommends, for example, making a more predictable but still quick process to account for devices that are too novel for 510(k)s, but not risky enough to warrant full-blown premarket approval. They also want a better definition of those devices that are 510(k)-worthy, and yet would still require some clinical or manufacturing data to satisfy FDA. Right now, applicants are often unpleasantly surprised to learn FDA wants that information only after filing.
Ever seeking a balance between protecting the public health and speeding new, innovative products to market, the FDA says its “three key objectives” regarding its public health mission for devices are to “foster device innovation, create a more predictable regulatory environment, and enhance device safety.”
Industry no doubt welcomes any useful method to improve predictability in this sometimes baffling area, and the FDA gives you the chance to shape these reports. The preliminary reports have been formulated with substantial public input, and FDA has asked for further public input on these preliminary reports. If you think these recommendations would affect your business one way or another, this is a good opportunity to place some facts before the agency to help shape policy changes. To do so, see www.
fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm.
--By Eric Greenberg, Attorney-at-Law
