federal_register: E9-19683
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E9-19683 | Medical Device Reporting: Electronic Submission Requirements | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting would improve the agency's process for collecting and analyzing postmarket medical device adverse event information. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. Elsewhere in this issue of the Federal Register, FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation. The proposal also includes modifications to the regulations specifying the content of required MDRs to better track information already solicited on the FDA Form 3500A. | 2009-08-21 | 2009 | 8 | https://www.federalregister.gov/documents/2009/08/21/E9-19683/medical-device-reporting-electronic-submission-requirements | https://www.govinfo.gov/content/pkg/FR-2009-08-21/pdf/E9-19683.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also... |