federal_register: 2017-23195
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-23195 | Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff." This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This draft guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program. This draft guidance is not final nor is it in effect at this time. | 2017-10-25 | 2017 | 10 | https://www.federalregister.gov/documents/2017/10/25/2017-23195/breakthrough-devices-program-draft-guidance-for-industry-and-food-and-drug-administration-staff | https://www.govinfo.gov/content/pkg/FR-2017-10-25/pdf/2017-23195.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff." This guidance document describes policies... |