Source: http://www.law.cornell.edu/cfr/text/21/part-803?qt-cfr_tabs=3
Timestamp: 2014-07-22 22:36:45
Document Index: 598898394

Matched Legal Cases: ['art 803', 'art 803', 'art 803', '§ 803', '§ 803', '§ 803', '§ 803', '§ 803', 'art 803', '§ 352', '§ 360', '§ 360', '§ 360', '§ 371', '§ 374']

21 CFR Part 803 - MEDICAL DEVICE REPORTING | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 803 21 CFR Part 803 - MEDICAL DEVICE REPORTING
There are 2 Updates appearing in the Federal Register for 21 CFR 803. View below or at eCFR (GPOAccess)
SUBPART A — General Provisions (§§ 803.1 - 803.19)
SUBPART B — Generally Applicable Requirements for Individual Adverse Event Reports (§§ 803.20 - 803.22)
SUBPART C — User Facility Reporting Requirements (§§ 803.30 - 803.33)
SUBPART D — Importer Reporting Requirements (§§ 803.40 - 803.42)
SUBPART E — Manufacturer Reporting Requirements (§§ 803.50 - 803.58)
21 U.S.C. 352, 360, 360i, 360j, 371, 374.
70 FR 9519, July 13, 2005, unless otherwise noted
Title 21 published on 2013-04-01The 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.2014-02-14; vol. 79 # 31 - Friday, February 14, 201479 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
typeregulations.gov FR Doc.2014-03279 RIN0910-AF86 Docket No.FDA-2008-N-0393 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective August 14, 2015 (see also section IX of this document). 21 CFR Part 803 SummaryThe Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to 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 will improve the Agency&apos;s process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 352 - Misbranded drugs and devices§ 360 - Registration of producers of drugs or devices§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings§ 374 - Inspection
Title 21 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 803 after this date.2014-02-14; vol. 79 # 31 - Friday, February 14, 201479 FR 8832 - Medical Device Reporting: Electronic Submission Requirements