federal_register: 2017-26457

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2017-26457 Fostering Digital Health Innovation: Developing the Software Precertification Program; Public Workshop; Request for Comments Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Fostering Digital Health Innovation: Developing the Software Precertification Program." The purpose of the public workshop is to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take into account real world evidence while incorporating principles established through international harmonization. 2017-12-08 2017 12 https://www.federalregister.gov/documents/2017/12/08/2017-26457/fostering-digital-health-innovation-developing-the-software-precertification-program-public-workshop https://www.govinfo.gov/content/pkg/FR-2017-12-08/pdf/2017-26457.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Fostering Digital Health Innovation: Developing the Software Precertification Program." The purpose of the public workshop is to discuss the...

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