Today, Federal Register published the FDA's recommended draft guidance about Pediatric Uses of Medical Devices requesting comments. Under the Food and Drug Administration Amendments Act of 2007 ("FDAAA") medical device companies are suggested to include certain information related to the potential impact of a disease on any pediatric subpopulations. Prior FDA attempts in February 2013 faced intense industry resistance as such process was characterized as being unduly burdensome on the industry.
However, the FDA maintains that such process is not unduly burdensome per submission, because not all readily available information are required to be submitted. The Notice can be found at http://www.gpo.gov/fdsys/pkg/FR-2013-12-16/pdf/2013-29796.pdf
As such the FDA's recommendation still applies to applicants who submit the following applications: (1) Any request for a humanitarian device exemption submitted under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD Act) (21 U.S.C. 360j(m)); (2) Any premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the FD Act (21 U.S.C. 360e); and (3) any product development protocol submitted under section 515 of the FD&C Act. How such information will be used remains to be seen. Notice requests all comment to be submited by Jan 15, 2014.
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