federal_register: 2014-29800
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-29800 | Independent Assessment of the Process for the Review of Device Submissions; Final Implementation Plan | Notice | The Food and Drug Administration (FDA) is announcing the availability on FDA's Web site of the Agency's final implementation plan published as part of Booz Allen Hamilton's independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years (FYs) 2013-2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter dated April 18, 2012, and entitled "MDUFA Performance Goals and Procedures" (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final implementation plan is FDA's response to Booz Allen Hamilton's comprehensive findings and recommendations and the final deliverable resulting from the first phase of the assessment. | 2014-12-22 | 2014 | 12 | https://www.federalregister.gov/documents/2014/12/22/2014-29800/independent-assessment-of-the-process-for-the-review-of-device-submissions-final-implementation-plan | https://www.govinfo.gov/content/pkg/FR-2014-12-22/pdf/2014-29800.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability on FDA's Web site of the Agency's final implementation plan published as part of Booz Allen Hamilton's independent assessment of the process for the review of medical device... |