federal_register: 2012-30511
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-30511 | Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments | Notice | The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an 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 2013-2017. The assessment is described in section V, "Independent Assessment of Review Process Management", of the commitment letter entitled "MDUFA Performance Goals and Procedures" \1\ (MDUFA III Commitment Letter). The assessment will be conducted by an independent contractor in two phases. FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment. --------------------------------------------------------------------------- | 2012-12-19 | 2012 | 12 | https://www.federalregister.gov/documents/2012/12/19/2012-30511/comprehensive-assessment-of-the-process-for-the-review-of-device-submissions-request-for-comments | https://www.govinfo.gov/content/pkg/FR-2012-12-19/pdf/2012-30511.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments... |