[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