FDA Seeking Comment on Device Reclassification Policy

Public comment is being requested through January 13, 2012 by the US Food and Drug Administration regarding data collection requirements for medical device reclassification petitions.

Currently, manufacturers and sponsors seeking to reclassify their devices with the FDA must submit supplemental data sheets (Form FDA 3427) and classification questionnaires (Form FDA 3429) to address safety and effectiveness of their products. Scientifically valid evidence supporting manufacturers’ arguments that reclassification of their devices will uphold safety and effectiveness is also required.

The FDA sees no capital, operating or maintenance costs associated with manufacturers’ collection and submission of this information. Based on records of reclassification petitions filed over the past three years, the agency expects an average of six petitions to be filed on an annual basis; each petition typically requires 500 hours to prepare and submit.

By requesting comment on the policy, the FDA is apparently reconsidering the depth and breadth of requirements associated with reclassification petitions. A more lenient process may lead to higher volumes of reclassification requests from industry.

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