Source: https://www.law.cornell.edu/cfr/text/21/803.30?qt-cfr_tabs=2
Timestamp: 2015-09-05 10:58:36
Document Index: 418337845

Matched Legal Cases: ['art 803', '§ 803', '§ 803', '§ 803', '§ 803', 'art 803', '§ 803', 'ART 803', '§ 803', '§ 803', '§ 803', '§ 803', 'art 803', 'art 803']

There is 1 rule appearing in the Federal Register for 21 CFR Part 803. View below or at eCFR (GPOAccess)
You must submit reports to the manufacturer or to us, or both, as specified below:
Reports of death.
You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must report information required by § 803.32 on FDA Form 3500A or an electronic equivalent approved under § 803.14.
Reports of serious injury.
You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by § 803.32 on FDA Form 3500A or an electronic equivalent approved under § 803.14.
What information does FDA consider “reasonably known” to me? You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.
At 79 FR 8846, Feb. 14, 2014, part 803 was revised, and § 803.58 was suspended indefintely, effective Aug. 14, 2015. For the convenience of the user, the revised text appears as follows:
PART 803—MEDICAL DEVICE REPORTING (Eff. 8-14-15)
You must submit reports to the manufacturer or to us, or both, as specified in paragraphs (a)(1) and (a)(2) of this section as follows:
You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(b).
You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12 (b).
What information does FDA consider “reasonably known” to me?
You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.
Title 21 published on 2014-04-01.The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2015-02-27; vol. 80 # 39 - Friday, February 27, 201580 FR 10586 - Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments
typeregulations.gov FR Doc.2015-03943 RIN0910-AF86 Docket No.FDA-2008-N-0393 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correcting amendments. This rule is effective August 14, 2015. 21 CFR Part 803 SummaryThe Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact information listed in the regulations.
Title 21 published on 2014-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 803 after this date.2015-02-27; vol. 80 # 39 - Friday, February 27, 201580 FR 10586 - Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments