FDA has no way to track or regulate devices sold on eBay or similar auction sites.
What can device manufacturers do to prevent unauthorized Internet sales? Apparently not much, other than alert FDA.
“There's a real concern on behalf of many of our members,” says Mark Leahey, executive director of the Medical Device Manufacturers Association. “The underlying patient safety issue has been compounded now that we've found out that these products are being sold online or at sites like eBay. Once the product is out of the manufacturers' [hands], they can't guarantee that when it gets to the hospital, it hasn't been doctored, or that something has happened to it.”
Leahey also questioned the trustworthiness of some products sold on eBay, as well as how the site validates who buys products that require a prescription. “When dealing with healthcare, there has to be a hypersensitivity. EBay is a great platform for certain transactions, but certainly I don't think it is appropriate for medical devices.”
According to Larry Spears, FDA cannot and does not have a way of tracking or regulating devices sold on eBay or similar auction sites. “EBay isn't subject to our requirements, because it is only a middleman,” says Spears. “We have no authority to regulate eBay.” The Web site doesn't take ownership of products, nor does it transfer products, he explains. Spears is deputy director for regulatory affairs in CDRH's Office of Compliance.
FDA has been working with eBay on screening advertisements before they are posted or on having inappropriate ones removed after they appear. FDA also tries to monitor high-risk products, such as those that require a prescription or are implanted in the body.
“If we see [advertisements] once they've gone up and get them taken down, that's about the best that we can do,” says Spears. He adds that pursuing an individual would be nearly an “impossible task.”
“We typically regulate companies. If it's a company that's selling its products on eBay, we can follow up with it,” says Spears. “With individuals, it's very hard to track down a person who is selling out of his or her home. We're just not going to do that—it's not the way we operate.”
Ultimately, the seller is held responsible. “But the question is, are we going to be able to find out who the sellers are?” asks Spears. “And depending on who they are, we have to decide whether it's worth going after them. We have to prioritize. If we're talking about a high-risk device, then clearly we're going to be interested. If it's a pair of clamps that one person is selling, we may not.”
If a product is sold illegally, the seller is subject to the same legal requirements as any manufacturer. “That's a violation, and as a company, they would be subject to a warning letter,” says Spears. “For an individual selling one product that doesn't have a 510(k) but should, we're not likely to try to find out who he or she is.” Spears says having the advertisement removed is usually enough action. So far, eBay has been responsive in removing ads that FDA has indicated were inappropriate.
Some sellers place a disclaimer in their eBay ads. They usually state that the items are subject to FDA regulation, and that the seller will verify that the buyer is authorized to use the item before it is shipped.
“It would be our preference to not have [any devices sold] on eBay, but eBay isn't going to go that far,” says Spears. “We've just tried to work out the best agreement we can with them, recognizing that they don't have to do any of this. They could put us in a situation where they say, ‘FDA, you just go after everyone if you want; we're not going to do anything.'”