This collection
is approved through 8/00 consistent with the previous terms of
clearance. Specifically, FDA will (1) continue to redesign the data
ocllected under the current Medical Device Reporting (MDR) program
including the 3500A, the Baseline Report, and the Medical Device
Registration and Listing Process; (2) present the redesign to OMB
and the regulated community prior to the resubmission to OMB; (3)
make appropriate revisions and subject the redesigned forms to
public comment prior to the OMB submission. As agreed to
previously, FDA shall take particular care to work closely with
interested parties who will be affected by any changes to the form
and will address in detail any changes in the resubmission any
comments received. This collection has been previously extended
numerous times for this purpose. It will not be extended in the
future until these conditions are met in full.
Inventory as of this Action
Requested
Previously Approved
08/31/2000
08/31/2000
11/30/1999
328,361
0
298,570
320,081
0
289,005
0
0
6,427,000
Reporting of adverse events and
product problems by health professionals to the FDA either directly
or via the manufacturer is critical to an effective national
postmarketing surveillance system. The overall MedWatch program is
a national educational/ promotional initiative designed both to
educate all health professionals about the critical importance of
being aware of, monitoring for, and reporting adverse events and
problems to FDA and/or the manufacturer and to ensure that new
medical products' safety information is communicated rapidly to the
health professional community, thereby improving patient
care.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
MedWatch: The FDA Medical Products Reporting Program