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William Sutton, deputy director of the Division of Small Manufacturers, International and Consumer Assistance

Registering a medical device firm with FDA and establishing a medical device listing are two crucial steps to marketing a medical device in the United States. The registration establishes an OEM as just that—a device maker that plans to introduce products to market. "It lets FDA know where you are, and that you’re doing something that requires GMP or QSR compliance," explained William Sutton, deputy director of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA). Sutton spoke at a conference at MD&M West in January 2006.

The listing of devices tells the agency which company is releasing which products onto the market. "It tells FDA whose name is on the device," noted Sutton. There is no approval process to be registered or to have a device listed, and all device manufacturers must register and list their devices with FDA.

Sounds simple, right? It is—if you make a Class I device that doesn’t need a 510(k) clearance. For other cases, it gets more complicated.

For example, a company with a device that requires 510(k) clearance to market the device cannot fill out FDA-2892, the Medical Device Listing form, until the product is cleared. "There is a line on the form that asks for the 510(k) approval number," said Sutton, "and if you leave it blank, FDA will send the form right back to you."

What about contract manufacturers, or firms that provide services or parts to an OEM? Because these so-called specification manufacturers must have a quality system in place to ensure they make the parts correctly, they must register with FDA using FDA-2891, the Initial Registration of Medical Device Establishment. However, because they do not produce the finished device that the end-user sees, they do not get a device listing.

But now consider firms that provide spare parts or replacements. Each of these instances must be considered carefully. "The questions to ask are, 'Where are these parts coming from, and who is getting them?'" Sutton noted. If the OEM is releasing them to the end-user, then no new listing is needed. But, if another company is providing them to the end-user, they need to be registered with FDA as a medical device establishment.

Third-party aftermarket repair, refurbishing, or reprocessing firms are not required to register with FDA or list the devices. "FDA has found few issues of concern in these cases," Sutton said, "so it doesn’t seem to be a problem." However, he cautioned, such situations are not to be confused with reprocessing of single-use devices, which are now regulated by FDA. Recent FDA regulations have mandated that reprocessing firms must not only register with the agency, but they must also demonstrate the reprocessed devices are as safe and effective as the predicate devices.

Sutton pointed to FDA’s Web site as a good starting place to decide whether a company should be registered and have a medical device listing. He also pointed out that the offices within CDRH, such as DSMICA, are excellent resources and can answer many questions on this topic.