[Federal Register Volume 69, Number 31 (Tuesday, February 17, 2004)]
[Notices]
[Pages 7490-7492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3333]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0016]
Medical Devices; Revised MedWatch Forms; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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[[Page 7491]]
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the revised MedWatch Voluntary Reporting Form (FDA Form
3500), the revised Mandatory Reporting Form (3500A), and the respective
instructions for each form.
DATES: The revised MedWatch forms are effective immediately. The forms
were approved by the Office of Management and Budget (OMB) on September
12, 2003 (see 68 FR 58691, October 10, 2003); however, reporters may
continue to use the prior version of Forms 3500 and 3500A until August
17, 2004.
FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices
and Radiological Health (HFZ-531), 1350 Piccard Dr., Rockville, MD
20850, 301-827-2983.
SUPPLEMENTARY INFORMATION:
I. Background
Section 303 of the Medical Device User Fee and Modernization Act of
2002 (MDUFMA) amended the Federal Food, Drug, and Cosmetic Act (the
act) to require FDA to modify Forms 3500 and 3500A, the MedWatch
voluntary and mandatory reporting forms respectively, to facilitate the
reporting, by user facilities or distributors, of adverse events
involving single-use devices (SUDs) that have been reprocessed for
reuse in humans. The following two questions were added to the revised
MedWatch forms: (1) Is this a single-use device that was reprocessed
and reused on a patient? and (2) If yes, enter the name and address of
the reprocessor.
II. Comments
In the Federal Register of April 29, 2003 (68 FR 22716), FDA
published a notice requesting public comment on the information
collection provisions. FDA received several comments.
One comment stated that there are no affirmative mechanisms that
would allow original equipment manufacturers (OEMs) to detect when a
single-use device had been reprocessed.
FDA disagrees with this comment. We believe that there are several
ways an OEM can ascertain whether a single-use device has been used and
reprocessed.
Under Sec. 803.50(b) (21 CFR 803.50(b)), the medical device
reporting regulation (MDR), manufacturers are obligated to report
information that is reasonably known to them. The information that is
reasonably known to a manufacturer includes information that: (1) Can
be obtained by contacting the user facility, importer, or other initial
reporter; (2) is in the manufacturer's possession, or (3) can be
obtained by analysis, testing, or evaluation of the device (see Sec.
803.50(b)).
If an OEM has reason to believe that the SUD has been reprocessed,
there are a number of steps the OEM can take to follow up. The OEM can
contact either the user facility or the reporter to determine if the
SUD was reprocessed and reused on a patient (question D8 of both Forms
3500 and 3500A). This information should be readily available to a user
facility since the practice of reusing reprocessed SUDs generally
requires the user facility to have in place a written policy,
procedure, or contract that supports this practice. In all cases, FDA
recommends that requests for information to user facilities or
individual reporters be in writing so that the OEM has documentation
about its reasonable efforts to determine if the SUD was reprocessed
and reused on a patient. In addition, OEMs may already be in possession
of information, such as reports from their sales representatives, which
will help them determine if an SUD was reprocessed. An OEM can conduct
testing and analysis of any SUD that has been returned to them to try
to get additional information about whether the device was reprocessed.
FDA believes that there may be occasional situations where an OEM
has exhausted all reasonable mechanisms to determine whether the SUD
has been reprocessed and is still unable to determine its status. In
that event, the OEM should enter ``UNK'' (unknown) in block D8 and
report in block H10 of the 3500A form that it is unable to determine if
the suspect device was reprocessed and reused on a patient. The OEM
also should describe in block H10, the steps the OEM took to try to
obtain the information, including any responses from user facilities or
other reporters. The OEM's MDR files should include supporting
documentation for what has been reported in block H10.
FDA wishes to emphasize that it considers any entity that
reprocesses an SUD for reuse in humans to be the manufacturer of the
reprocessed SUD and, accordingly, subject to all the regulatory
requirements currently applicable to OEMs, including the responsibility
for MDR reporting. Therefore, if an OEM determines that an SUD has been
reprocessed for reuse in humans, the OEM has no further MDR obligation
for the device involved in this event. The OEM should forward all of
the information concerning the event to FDA and state in the cover
letter that the SUD was reprocessed. In that case, the SUD is not the
OEM's device, but rather is now the reprocessor's device (see Sec.
803.22(b)(2) (21 CFR 803.22(b)(2)).
One comment referred to an apparent conflict between the amended
section 303 of MDUFMA and MDR (Sec. 803.52(f)(11)(i) and (f)(11)(iii)),
which requires manufacturers to provide corrected and/or missing data
on the MedWatch form. If the data are not provided, the manufacturer is
required to explain why the information was not provided and the steps
that were taken to obtain the information.
FDA disagrees with this comment. We do not believe that there is a
conflict between section 303 of MDUFMA and the MDR regulation. The
purpose of section 303 of MDUFMA was to facilitate the reporting of
information relating to reprocessed SUDs. We believe that this
information will come primarily from user facilities, which generally
have in place policies, procedures, or agreements supporting the reuse
of reprocessed SUDs. As stated previously, once an OEM determines that
the SUD has been reprocessed by either contacting the user facility,
reviewing information in the firm's possession, or by testing or
evaluating the device itself, the OEM is no longer responsible for
reporting the event or any information related to the event.
A comment addressed the redesign of both forms FDA 3500 and FDA
3500A. The comment suggested revising sections F and H of the mandatory
MedWatch form (FDA Form 3500A) and section D of the voluntary MedWatch
Form (FDA Form 3500).
FDA disagrees with this comment. The MedWatch forms are used by all
entities that report to the agency. However, the two new questions
pertain only to medical devices. Consequently, we redesigned the forms
to limit the changes to those required under MDUFMA. The instructions
for completing the revised Forms 3500 and 3500A have been modified
accordingly and are available on FDA's MedWatch Web site (see III.
Availability of Forms).
Some comments requested to extend the deadline to comply with the
revised forms. Initially, one comment asked that manufacturers be given
until September 30, 2005, to comply with the revised form. A later
comment suggested providing a 1-year interim period for industry to
modify their reporting systems.
FDA partially agrees with the comments. Congress required FDA to
modify the MedWatch forms by April 26, 2003. We agree that a reasonable
period of time is needed for medical device reporters to incorporate
the two new questions into their reporting systems. In the October 10,
2003, notice, FDA announced that OMB approved the information
collection for the MedWatch program. At FDA's request, OMB approved the
continued use of the previous forms for 6 months to allow
[[Page 7492]]
time for the reporters to make the necessary changes to their
computerized systems.
During this transitional period FDA will accept both the newly
effective Forms 3500 and 3500A and the prior versions of the forms.
Information concerning the reuse of the product (new question D8) and
the name and address of the reprocessor (new question D9) can be
provided in section H10 on the prior version of form 3500A (OMB
approval date, November 2002). Reporters may continue to use the prior
version of Forms 3500 and 3500A until [insert date 6 months after date
of publication in the Federal Register]. During this 6-month period,
the prior versions and the instructions will be available on FDA's
Center for Devices and Radiological Health MDR Web site at http://www.fda.gov/cdrh/mdr/mdr-forms.html.
III. Availability of Forms
The newly revised MedWatch forms are available at FDA Form 3500
http://www.fda.gov/medwatch/safety/3500.pdf and FDA Form 3500A http://www.fda.gov/medwatch/safety/3500a.pdf.
The instructions for the revised forms are available at FDA Form
3500 http://www.fda.gov/medwatch/report/consumer/instruct.htm and FDA
Form 3500A http://www.fda.gov/medwatch/report/instruc.htm.
Dated: January 30, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. 04-3333 Filed 2-13-04; 8:45 am]
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