federal_register: 2016-25659

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-25659 Program for Parallel Review of Medical Devices Notice The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) (the Agencies) are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely. The Agencies are soliciting nominations from manufacturers of innovative medical devices to participate in the "Program for Parallel Review of Medical Devices." The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA's granting of a de novo request and Medicare coverage decisions through CMS's National Coverage Determination (NCD) process. This program is intended to ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population. 2016-10-24 2016 10 https://www.federalregister.gov/documents/2016/10/24/2016-25659/program-for-parallel-review-of-medical-devices https://www.govinfo.gov/content/pkg/FR-2016-10-24/pdf/2016-25659.pdf Health and Human Services Department; Centers for Medicare & Medicaid Services; Food and Drug Administration 221,45,199 The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) (the Agencies) are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely. The...  

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