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federal_register: 2010-17617

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-17617 Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Withdrawal Rule The Food and Drug Administration (FDA) published in the Federal Register of April 1, 2010, 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. The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment. 2010-07-20 2010 7 https://www.federalregister.gov/documents/2010/07/20/2010-17617/medical-devices-pediatric-uses-of-devices-requirements-for-submission-of-information-on-pediatric https://www.govinfo.gov/content/pkg/FR-2010-07-20/pdf/2010-17617.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) published in the Federal Register of April 1, 2010, a direct final rule that was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available...

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