Some may think the FDA does not take what industry has to say to heart or feel that there is no point in commenting on a proposed rule, because their feedback is left unread.

FDA published a proposed rule1 for 515(a)2 in 2010 (Docket No. FDA–2009–N–0458) and a direct final rule3. FDA took the comments into consideration and after reviewing the comments received in response, the direct rule was withdrawn by FDA4.

A new supplemental proposed rule5, as well as related draft guidance6, was issued by the FDA last Tuesday, February 19, 2013, in order to add clarity to the expectations of pediatric medical device submissions and to shed more light on what “readily available information” is.

The proposed rule requires the inclusion of “readily available” pediatric information in any HDE, PMA, or PMA supplement, or PDP5. To drive this point home, the guidance document describes the current thinking and recommendations on how to compile, as well as submit, the readily available pediatric use information that is required under Section 515A of the FD&C Act5.

So, what exactly does “readily available information” mean?

The proposed rule5 and draft guidance6 defines “readily available information” as, “information that is available in the public domain” and states, “[a]ll submitted pediatric device use information should be available through commonly used public resources for conducting biomedical, regulatory, and medical product research.”

Reliable sources would include research published in peer-reviewed medical and scientific journals, such as the Journal of the American Medical Association (JAMA) or PubMed. National Ambulatory Medical Care Survey (NAMCS) is an example of an acceptable survey source to obtain “readily available information” from. Other examples of acceptable “readily available information” sources include the following: MedlinePlus, Medscape, , Cochrane Library, National Institutes of Health (NIH), and U.S. National Library of Medicine (NLM).

In the future, if you see a proposed rule that is open for comment and you have appropriate and constructive commentary, make sure your voice is heard by participating in the open commentary period! Open comments are not left unheard/unread!

For more information on how to comment, feel free to take a look at my “New Year, New Resolutions” blog from January!

-RSpelich ^_^

References

1.) Federal Register. Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease of Condition That a Device Is Intended to Treat, Diagnose, or Cure. 2010;75(62):16365-70. Available at: http://www.raps.org/focus-online/news/news-article-view/article/2882/fda-looks-to-finally-implement-pediatric-data-requirements-for-most-device-subm.aspx. Accessed 25 Feb. 2013.

2.) Federal Register. 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; Direct Final Rule. 2010;75(62):16347-51. Available at: http://www.gpo.gov/fdsys/pkg/FR-2010-04-01/pdf/2010-7193.pdf. Accessed 25 Feb. 2013.

3.) FDA. Food and Drug Administration Amendments Act (FDAAA). Last updated 02 Dec. 2011. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm. Accessed 25 Feb. 2013.

4.) Gaffney, A. FDA Looks to Finally Implement Pediatric Data Requirements for Most Device Submissions. Regulatory Focus. Retrieved from: http://www.raps.org/focus-online/news/news-article-view/article/2882/fda-looks-to-finally-implement-pediatric-data-requirements-for-most-device-subm.aspx. Accessed 25 Feb. 2013.

5.) Federal Register. 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. 2013;78(33): 11612-7. Available at: http://www.gpo.gov/fdsys/pkg/FR-2013-02-19/html/2013-03647.htm. Accessed 25 Feb. 2013.

6.) USDHHS, FDA, CDRH, and CBER. Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act. 19 Feb. 2013. Rockville, MD. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339465.pdf. Accessed 25 Feb. 2013.

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