[Code of Federal Regulations]
[Title 21, Volume
8]
[Revised as of April 1, 2002]
From the U.S.
Government Printing Office via GPO Access
[CITE:
21CFR803.50]
[Page
52]
TITLE 21--FOOD AND
DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
(CONTINUED)
PART 803--MEDICAL DEVICE REPORTING--Table
of Contents
Subpart
E--Manufacturer Reporting Requirements
Sec. 803.50
Individual adverse event reports;
manufacturers.
(a)
Reporting standards. Device manufacturers are required to
report
within 30 days whenever the manufacturer receives
or otherwise becomes
aware of information, from any
source, that reasonably suggests that a
device marketed by
the manufacturer:
(1) May
have caused or contributed to a death or serious injury;
or
(2) Has malfunctioned and
such device or similar device marketed by
the manufacturer
would be likely to cause or contribute to a death or
serious injury, if the malfunction were to
recur.
(b) Information that
is reasonably known to manufacturers. (1)
Manufacturers
must provide all information required in this subpart E
that is reasonably known to them. FDA considers the
following
information to be reasonably known to the
manufacturer:
(i) Any
information that can be obtained by contacting a user
facility, importer, or other initial
reporter;
(ii) Any
information in a manufacturer's possession;
or
(iii) Any information that
can be obtained by analysis, testing or
other evaluation
of the device.
(2)
Manufacturers are responsible for obtaining and providing FDA
with information that is incomplete or missing from
reports submitted by
user facilities, importers, and other
initial reporters. Manufacturers
are also responsible for
conducting an investigation of each event and
evaluating
the cause of the event. If a manufacturer cannot provide
complete information on an MDR report, it must provide a
statement
explaining why such information was incomplete
and the steps taken to
obtain the information. Any
required information not available at the
time of the
report, which is obtained after the initial filing, must be
provided by the manufacturer in a supplemental report
under Sec.
803.56.
[60 FR 63597, Dec. 11, 1995, as
amended at 66 FR 23157, May 8,
2001]
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