federal_register: 2016-16350
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-16350 | Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; 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 guidance entitled "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device." This guidance describes the types of information that should be provided to support a claim of EMC in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (i.e., cause an electromagnetic interference (EMI)). EMC assessment helps to ensure that a device is able to function in its intended environment without introducing excessive electromagnetic disturbances that might interfere with other devices. | 2016-07-11 | 2016 | 7 | https://www.federalregister.gov/documents/2016/07/11/2016-16350/information-to-support-a-claim-of-electromagnetic-compatibility-of-electrically-powered-medical | https://www.govinfo.gov/content/pkg/FR-2016-07-11/pdf/2016-16350.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 guidance entitled "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device." This guidance describes the types... |