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.
Sounds simple, right? It is—if you make a Class I device that does not need a 510(k) clearance. For other cases, it gets more complicated.
“The registration lets FDA know where you are and that you're doing something that requires GMP or QSR compliance,” explained William Sutton, deputy director of DSMICA. Sutton spoke at MD&M West. Not every entity that is subject to the Quality System Regulation (QSR) is required to register. Domestic U.S. contract manufacturers and contract sterilizers who do not commercially distribute devices are subject to the QSR but are exempt from registration and listing
The listing of devices tells the agency the type and class of device the owner or operator is introducing into commercial distribution. 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.
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? Domestic contract manufacturers that do not commercially distribute a device are not subject to registration and listing. However, they are subject to the QSR and FDA inspection. Foreign contract manufacturers that ship finished devices, as defined by 21 CFR 820.3(l), to the United States are subject to registration and listing. Firms that solely provide services or parts to an OEM are not required to register and list. If these services or parts are commercially distributed by the firm to the OEM's customers, then they may have to register and list.
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. Manufacturers of parts are not usually required to register. If they do have to register, then they also have to list. The only parts manufacturers that register or list are those that sell classified devices or accessories to the end user. If they only sell to the OEM, they are not required to register and list.
Third-party aftermarket repair, refurbishing, or reprocessing firms are not required to register with FDA or to list the devices. Although FDA does have concerns with third party refurbishers and continues to monitor these types of establishments, limited resources do not currently allow the FDA to expend resources to routinely inspect these establishments. However, he cautioned, such situations are not to be confused with single-use device reprocessors, 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 that 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.