federal_register: E8-11909
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-11909 | Medical Devices; Hearing Aids; Technical Data Amendments | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are proposing to amend the regulations to require manufacturers to use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also proposing to amend the regulations to update an address and remove an outdated requirement. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. | 2008-06-02 | 2008 | 6 | https://www.federalregister.gov/documents/2008/06/02/E8-11909/medical-devices-hearing-aids-technical-data-amendments | https://www.govinfo.gov/content/pkg/FR-2008-06-02/pdf/E8-11909.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids.... |