[Federal Register Volume 69, Number 31 (Tuesday, February 17, 2004)]
[Pages 7490-7492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3333]



Food and Drug Administration

[Docket No. 2003N-0016]

Medical Devices; Revised MedWatch Forms; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.


[[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.


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 
    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. 
    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]