Reps. Rogers and Markey Introduce Bill to Implement Withdrawn Pediatric Medical Device Rule

February 10, 2012

By Jennifer D. Newberger –

On Wednesday, February 8, Representatives Mike Rogers (R-MI) and Ed Markey (D-MA) introduced H.R. 3975, The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012.  The bill would put into effect a rule previously withdrawn by FDA regarding the inclusion of pediatric information in certain medical device submissions to FDA, notwithstanding the requirements of the Administrative Procedure Act ("APA") to obtain and consider public input prior to implementing a final rule. 

A little background to the withdrawn rule is helpful in understanding the intent of this bill.  On April 1, 2010, FDA issued a proposed rule along with a direct final rule “that was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols.”  Although the rule was intended to be noncontroversial, the agency received “significant adverse comment” and therefore withdrew the direct final rule on July 19, 2010. 

The withdrawal of the direct final rule due to receipt of significant adverse comment indicates that the APA worked precisely as intended—to allow for public participation in the rulemaking process.  This seems to be of no matter to the sponsors of this bill, which would have the withdrawn direct final rule take effect on January 1, 2013, notwithstanding the APA “and any other provision of law.” 

Certainly, just as Congress created the APA, it can create exceptions to the APA.  Before doing so, however, it should consider whether it truly wants to force upon the public a rule much of the public explicitly decried. 

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Categories: Medical Devices