[Federal Register Volume 60, Number 209 (Monday, October 30, 1995)]
[Notices]
[Pages 55275-55276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26927]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0343]


In Vitro Diagnostic Devices; Tier/Triage Management Initiative; 
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 consider a tier/triage management initiative for in vitro 
diagnostic devices (IVD's). This management initiative is intended to 
improve the balance between FDA resources and workload based on a tier/
triage device risk assessment. The purpose of the workshop is to obtain 
public comments and suggestions that will help FDA assess potential 
extensions and applications of the tier/triage management initiative of 
the Office of Device Evaluation (ODE), Center for Devices and 
Radiological Health (CDRH). A transcript of the meeting will be 
available from the Dockets Management Branch (address below).

DATES: The public workshop will be held on October 30, 1995, from 9 
a.m. to 4 p.m. Submit written notices of participation as soon as 
possible.

ADDRESSES: The public workshop will be held at the Parklawn Building, 
conference rooms D and E, 5600 Fishers Lane, Rockville, MD. Submit 
written requests to make a presentation at the meeting, including an 
outline of comments, to Kaiser Aziz or Clara Sliva, FAX 301-594-5941. 
Submit written comments on the management initiative to the Dockets 
Management Branch, (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. A transcript of the meeting 
will be available through the Dockets Management Branch. A limited 
number of overnight accommodations have been reserved at the Doubletree 
Hotel, Rockville, MD. Attendees requiring overnight accommodations may 
contact the hotel at 301-468-1100 and reference the FDA meeting group: 
``GBG.'' Reservations will be confirmed at the group rate based on 
availability. Persons with disabilities who require special assistance 
to attend or participate in the workshop can be accommodated if advance 
notification is provided to Sociometrics, Inc., Alice Hayes, 8300 
Colesville Rd., suite 550, Silver Spring, MD 20910, or FAX 301-608-
3542. The availability of appropriate accommodations cannot be assured 
unless prior notification is provided. There is no registration fee for 
this meeting.

FOR FURTHER INFORMATION CONTACT: Kaiser Aziz, or Clara Sliva, Center 
for Devices and Radiological Health (HFZ-440), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-3084, 
FAX 301-594-5941.

SUPPLEMENTARY INFORMATION:
     Over the past few years, ODE, CDRH, has made an effort to raise 
the quality of the premarket review of medical devices. In the Division 
of Clinical Laboratory Devices (DCLD) this has resulted in a movement 
from a descriptive to a data driven review process with emphasis on 
using voluntary standards or published design or statistical 
methodologies as a basis for product review. One consequence of this 
heightened review process has been an imbalance between workload and 
workforce resulting in a backlog of submissions.

[[Page 55276]]

    In June 1993, in order to address this backlog problem, ODE 
introduced a comprehensive management action plan for improving the 
efficiency of its administrative work process. One key item in this 
plan was introduction of a tier/triage program for applications. The 
tier/triage program was designed to allow levels of review to be 
commensurate with the device risk. Three review levels were established 
in an effort to ensure proper allocation of agency resources among 
device submissions:
    1. Tier I review: For submissions of low risk products, a review 
that focuses on labeling for intended use.
    2. Tier II review: For products associated with moderate risk, a 
review of labeling and scientific data that includes evaluation of data 
to substantiate product performance claims.
    3. Tier III review: For products associated with high risk or for 
products with technical features requiring detailed analysis to 
determine safety and effectiveness, a heightened review of labeling and 
scientific data. Frequently, advisory panel review and recommendations 
would be sought as a component of this type of review.
    After an assessment of how DCLD would participate in this important 
management initiative, it was decided that the review of IVD products 
would be divided between the Tier I and Tier II categories based on the 
assessment of the need to evaluate specific performance parameters 
(such as accuracy, precision, analytical sensitivity, and analytical 
specificity) as part of the review.
    Products that did not require a review of performance 
characteristics prior to use, such as urine cups, and general purpose 
media, were assigned Tier I status. Products that did require a review 
of performance characteristics, such as sodium, glucose, hemoglobin and 
other common analytes, were placed into the Tier II category.
    Because classification panels meeting in the late 1970's and early 
1980's had already exempted from the requirement for premarket review 
most IVD's for which performance characteristics were not considered 
important, only a handful of IVD's were assigned to the Tier I 
category. These, along with other Tier I products, were exempted from 
premarket notification in a final rule published in the Federal 
Register on December 7, 1994 (59 FR 63005) and another final rule 
published in the Federal Register on July 28, 1995 (60 FR 38896).
    The Health Industry Manufacturer's Association (HIMA) strongly 
believes that there are more premarket submissions for familiar and low 
risk products that should be subject to a Tier I or similar type 
review. As a result, last year HIMA developed and provided a flowchart 
for assigning products into the three tier categories based on 
classification status, clinical use of the product (stand-alone versus 
adjunct), and the familiarity of the analyte and method used. Their 
model is reported to be very reproducible and would provide for a 
significant increase in the number of products assigned Tier I status.
    The DCLD has extensively reviewed the HIMA proposal and has 
developed a slightly adjusted model also based on a flowchart 
methodology. Although there are moderate differences when the DCLD 
model is compared to the HIMA proposal, the effect of the DCLD modified 
triage flowchart is the same, that is, a significant number of products 
can be identified that are low risk and/or that represent well 
understood analytes or methodologies. Therefore, an increased number of 
products would trigger Tier I reviews.
    The DCLD is very interested in ways to redirect its work force to 
deal with newer and more complex submissions. However, DCLD is 
concerned with the implications of taking widely used, although 
familiar products, and subjecting them to a Tier I review and/or 
exempting them from review. The October 30, 1995, workshop is intended 
to provide an opportunity for public dialogue on these issues, and will 
include a presentation by HIMA and distribution of both the HIMA and 
DCLD flowcharts.

    Dated: October 25, 1995.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 95-26927 Filed 10-26-95; 11:12 am]
BILLING CODE 4160-01-F