The August 2010 edition of Pro Te: Solutio¹ reported on the Food and Drug Administration’s promulgation of its April 1, 2010, Direct Final Rule² implementing section 515A of the Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSIA).³

Implementation of the PMDSIA would have required applicants who submit certain medical device applications under section 515A(a) of the Act to include additional information, such as: 1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and 2) the number of affected pediatric patients.⁴

The Direct Final Rule for the PMDSIA was to go into effect on August 16, 2010. The FDA did not consider the PMDSIA controversial and thus did not anticipate receiving any significant adverse comments which would hinder the implementation of the PMDSIA.⁵ The FDA, however, was mistaken, and on July 20, 2010, the FDA withdrew the Direct Final Rule because “the agency received significant adverse comment.”⁶

In Spring 2011, the Office of Information and Regulatory Affairs released its Spring Edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions (“Unified Agenda”).⁷ Notably, the Spring 2011 Unified Agenda included the PMDSIA and lists February 2012 as the promulgation date for the PMDSIA “Final Rule.”⁸ If the PMDSIA Final Rule is in fact promulgated in February 2012, any adverse comments related to the Direct Final Rule will be addressed therein, and implantation of the PMDSIA should occur shortly thereafter.

[1] Available at <http://www.butlersnow.com/enewsletters_ Detail.aspx?id=4332>.

[2] FDA Direct Final Rule, Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure, 75 Fed. Reg. 16347 (April 1, 2010).

[3] 21 U.S.C.A. § 360e-1.

[4] 21 U.S.C.A. § 360e(a)(1) – (2); see also 75 Fed. Reg. 16347 (April 1, 2010). The FDA does not define the term “readily available” in this context.

[5] 75 Fed. Reg. 16366 (April 1, 2010).

[6] 75 Fed. Reg. 41986 (July 20, 2010).

[7] The Unified Agenda, published twice a year (usually in April and October), summarizes the rules and proposed rules that each Federal agency expects to issue during the next year.

[8] Department of Health and Human Services, Office of Information and Regulatory Affairs, “Requirement for Sub­mission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure,” Spring 2011, available at <http://www.reginfo.gov/public/do/eAgendaViewRulepubId=201104&RIN=0910-AG29> (last accessed Oct. 17, 2011).

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