or approval. The agency also looks for substantial new claims that are made without clearance. Investigational device inspections are conducted for clinical studies that may be submitted in a 510(k). FDA evaluates problems with imported products, including products subject to 510(k) clearance, and can detain products at the border, particularly if there is a violative inspection of a foreign facility. Most recalls are voluntary, whether of 510(k) or PMA devices, but on occasion FDA has exercised its mandatory recall authorities under the law. Additional 510(k)-related compliance activities in CDRH include sampling and testing of 510(k) products as needed.

Other components of CDRH monitor and evaluate the postmarket environment, not just from a manufacturing-environment standpoint but with reference to the clinical environment, trying to use information from all sources to gain an understanding of how products are performing in the marketplace. Ulatowski noted that FDA sometimes moves from surveillance to action, but the integration between these functions is not optimal.

FDA is trying to prevent problems, not only to react to them, and to identify issues related to risk as they emerge and deal with them strategically in a coordinated effort, not only with compliance activities but with educational efforts. Nevertheless, much time is spent in reacting to issues that come to light.



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