2011). About 90% of 510(k) submissions for Class I and Class II devices are cleared by the FDA to enter the market (GAO, 2009c).

A number of situations require a manufacturer to submit a 510(k) submission. By regulation, a new 510(k) notification must be submitted if

the device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification: (i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process; (ii) A major change or modification in the intended use of the device3 [see Figure 4-1].

Although they are not specified in the 510(k) regulation, there are generally four categories of parties who must submit a 510(k) submission to the FDA (FDA, 2010f):

1.   Domestic manufacturers introducing a device into the US market.

2.   Specification developers introducing a device into the US market.

3.   Repackagers or relabelers who have made labeling changes or whose operations substantially affect the device.

4.   Foreign manufacturers or exporters or US representatives of foreign manufacturers or exporters introducing a device into the US market.

The 510(k) clearance mechanism rests on the notion of “substantial equivalence.” A device must be found to be substantially equivalent to a predicate device if it is to be cleared through the 510(k) process for commercial distribution. To be considered substantially equivalent, devices must meet criteria that are detailed in Figure 4-1.

Congress has mandated that the FDA give priority review to PMA applications that have innovative or breakthrough technology.4 There is no legal framework for the FDA to request or consider whether a 510(k)-eligible device is innovative with the review process.

IMPLEMENTATION OF THE 510(K) PROCESS

The Medical Device Amendments of 1976 provided that all postamendment devices were automatically to be classified into Class III—that is, as high risk—with specific exceptions.5 The primary exception involved

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321 CFR § 807.81 (a)(3).

4FFDCA § 515(d)(5); 21 USC § 360e(d)(5) (2006).

5FFDCA § 513(f)(1), 21 USC § 360c(f)(1) (2006).



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