[Federal Register Volume 61, Number 160 (Friday, August 16, 1996)]
[Notices]
[Pages 42636-42637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20965]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 91N-0295]
RIN 0910-AA09
Medical Devices; Methods to Estimate Medical Device Denominator
Data; Notice of Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to gather and exchange information regarding the methods used
by the medical device industry to derive estimates of numbers of
devices manufactured, distributed, and in current use (collectively
referred to as denominator data) for purposes of submitting baseline
reports as required in the December 1995 medical device report (MDR)
final rule. This workshop is intended to help FDA better understand
these methods and therefore to better evaluate and utilize the
denominator data.
DATES: The public workshop will be held on September 17, 1996, from
8:30 a.m. to 6 p.m. Submit registration forms by September 10, 1996.
Persons wishing to make formal comments at the workshop must submit a
request with outline of their presentation on or before September 3,
1996.
ADDRESSES: The public workshop will be held at the Parklawn Building,
5600 Fishers Lane, Conference Rooms D and E, Rockville, MD 20857. A
proposed agenda and registration forms can be obtained after August 15,
1996, through the Center for Devices and Radiological Health (CDRH)
Facts-on-Demand system. To receive these documents via FAX call the
CDRH Facts-on-Demand system at 1-800-899-0381 or 301-827-0111 from a
touch-tone telephone. At the first voice prompt press 1 to access DSMA
Facts, at second voice prompt press 2, and then enter the document
number, 1053, followed by the pound sign (#), then follow the remaining
voice prompts to complete your request. Submit registration forms and
requests to make formal comments to the contact person below. A
transcript of the meeting may be available from the DSMA Facts line as
of October 4, 1996.
FOR FURTHER INFORMATION CONTACT: Roselie A. Bright, Center for Devices
and Radiological Health (HFZ-541), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-594-0600.
FDA is soliciting speakers from the industry to speak on methods they
use to estimate denominator data. Speakers representing these
categories of devices are being sought: Single use/disposable, multiple
use, and implantables. If you are interested in speaking, please call
the contact person as soon as possible. Speakers are asked to limit
their presentations to 10-15 minutes. There is no registration fee, but
advance registration is required due to space limitations. If you have
a disability that affects your attendance at, or participation in, this
meeting, please send a letter to the contact person and identify your
needs. The availability of appropriate accommodations cannot be assured
unless prior written notification is provided.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 1995
(60 FR 63578), the agency published the MDR final rule. On April 11,
1996, (61 FR 16043), FDA announced the effective date of the MDR final
rule was extended to July 31, 1996. On July 31, 1996 (61 FR 39868), the
agency issued a stay of the effective date for certain provisions of
the MDR final rule regarding baseline reporting requirements.
Under the December 11, 1995, final rule, manufacturers are required
to submit individual reports of adverse events on a monthly basis, as
well as annual baseline reports. Baseline reports are required, under
Sec. 803.55 (21 CFR 803.55), to include information specifically
identifying a device for which an adverse event has been submitted.
Under Sec. 803.55, manufacturers are also required to
[[Page 42637]]
submit denominator data for the device identified, which includes the
number of devices manufactured and distributed in the last 12 months,
an estimate of the number of devices in current use, and a brief
description of any methods used to estimate the number of devices
distributed and in current use. Based on comments received subsequent
to the issuance of the December 11, 1995, final rule, FDA stayed the
requirement to submit this denominator data pending further evaluation
(61 FR 39868).
During the stay, FDA has two projects planned: (1) A public
workshop and (2) a demonstration project. The agency is requesting
industry's assistance to accomplish both these projects. In preparation
for the demonstration project, CDRH is convening a public workshop to
enable the agency to better understand methods used to derive
denominator estimates and therefore better evaluate and utilize these
data.
For this workshop, CDRH is soliciting speakers from the medical
device industry to speak for approximately 10-15 minutes each on
methods they use to estimate denominator data. Given that methods may
vary by type of device, FDA is interested in hearing from members of
the medical industry representing three basic categories of devices:
Single use/disposable, multiple use, and implantables. After opening
remarks and background presentations by FDA, it is anticipating that
the workshop will include a series of presentations by industry members
representing these basic device categories in three sessions (one per
category) over 1 to 2 days. FDA intends to invite a group of
discussants, representing various disciplines (e.g., survey methods,
statistics, procurement, marketing, epidemiology), to listen and to
respond to the presentations. Several question and answer sessions are
also planned for the benefit of attendees.
At the completion of the public workshop and the demonstration
project, the agency will either lift the stay of the December 1995
final rule baseline denominator reporting requirements, retain the
stay, or issue a new proposed rule to modify these requirements.
Dated: August 12, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-20965 Filed 8-15-96; 8:45 am]
BILLING CODE 4160-01-F
