[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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