[Federal Register Volume 61, Number 37 (Friday, February 23, 1996)]
[Notices]
[Pages 7011-7012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4066]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0357]


Medical Devices; Investigational Devices; Interagency Agreement 
Between the Food and Drug Administration and the Health Care Financing 
Administration; Categorization of Investigational Devices for Coverage 
under Medicare; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of an interagency agreement between FDA and the Health 
Care Financing Administration (HCFA) and a list of all FDA-approved 
investigational device exemptions (IDE's) and their corresponding 
categorization determinations for possible Medicare reimbursement. This 
list was compiled in accordance with the categorization criteria set 
forth in the interagency agreement. The HCFA/FDA interagency agreement 
regarding investigational devices describes procedures by which FDA 
will assist HCFA in identifying nonexperimental/investigational devices 
that are potentially covered by Medicare under a final rule recently 
issued by HCFA extending coverage to certain devices and related 
services. FDA is making the interagency agreement and the list of FDA-
approved IDE's and their categorization determinations available to IDE 
sponsors and the public.

DATES: The HCFA final rule ``Medicare Program; Criteria and Procedures 
for Extending Coverage to Certain Devices and Related Services'' became 
effective on November 1, 1995. The HCFA/FDA interagency agreement 
became effective on September 8, 1995.

ADDRESSES: Submit written requests for a copy of the interagency 
agreement and the categorization list to the Division of Small 
Manufacturers Assistance (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Requests should be identified with 
the docket number found in brackets in the heading of this document. 
Send two self-addressed adhesive labels to assist that office in 
processing your request. Copies of the interagency agreement and the 
categorization list are available for public examination in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857 between 9 a.m. and 4 p.m., 
Monday through Friday. Copies of a facsimile of this information are 
available from the Center for Devices and Radiological Health's 
(CDRH's) Facts on Demand (1-800-899-0381). This information may also be 
obtained from the electronic docket administered by the Division of 
Small Manufacturers Assistance and is available to anyone with a video 
terminal or personal computer (1-800-252-1366, 1-800-222-0185, or 1-
301-594-2741). Requests for reconsideration of the categorization of an 
IDE should be submitted in the same manner as an IDE supplement and 
should reference the IDE number, and be submitted in triplicate to: IDE 
Document Mail Center (HFZ-401), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT: John Ensign, Center for Devices and 
Radiological Health (HFZ-404), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 19, 
1995 (60 FR 48417), HCFA published a final rule in which it announced 
that it would consider for Medicare coverage certain devices with an 
FDA-approved IDE that have been categorized as nonexperimental/
investigational. An FDA-approved IDE application permits a device which 
otherwise could not be lawfully shipped without marketing clearance, to 
be shipped lawfully for the purpose of conducting a clinical trial in 
accordance with section 520(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360j(g)) and 21 CFR parts 812 and 813.
    Under section 513 of the act (21 U.S.C. 360c), all devices must be 
classified into one of three regulatory classes: Class I (general 
controls), Class II (special controls), or Class III (premarket 
approval). For the purposes of consideration for reimbursement under 
the Medicare program and in accordance with the procedures set forth in 
the HCFA final rule published on September 19, 1995, FDA has 
categorized all FDA-approved IDE's into either Category A 
(experimental/investigational) or Category B (nonexperimental/
investigational). An experimental/investigational (Category A) device 
refers to an innovative device believed to be in Class III for which 
``absolute risk'' of the device type has not been established (that is, 
initial questions of safety and effectiveness have not been resolved, 
and the FDA is unsure whether the device type can be safe and 
effective). A nonexperimental/investigational (Category B) device 
refers to a device believed to be in Class I or Class II, or a device 
believed to be 

[[Page 7012]]
in Class III for which the incremental risk is the primary risk in 
question (that is, underlying questions of safety and effectiveness of 
the device type have been resolved), or it is known that the device 
type can be safe and effective because, for example, other 
manufacturers have obtained FDA approval for that device type. The 
specific criteria used to categorize the IDE's are set forth in 
Attachment A of the HCFA/FDA interagency agreement. In order to 
facilitate the processing of Medicare claims, FDA and HCFA encourage 
IDE sponsors to provide the IDE application numbers to the hospitals 
and clinical investigators participating in the sponsors' clinical 
investigations.
    According to the September 19, 1995, HCFA final rule, IDE's which 
have been placed in Category B by FDA would be eligible for Medicare 
coverage consideration. The final coverage decision, however, will 
encompass other factors and thus will be made by HCFA.
    By this notice, FDA is making available a list of all FDA-approved 
IDE's, the corresponding categorization determination (Category A or 
Category B), and the rationale for the determination. FDA will update 
this list as circumstances require and will make the revised list 
available through the electronic docket and Facts on Demand (details 
above), and in the Dockets Management Branch (address above). As set 
forth in the September 19, 1995, final rule, an IDE sponsor may seek 
reconsideration of a categorization determination by submitting a 
request for re-evaluation to FDA. Requests for re-evaluation should be 
submitted in the same manner as an IDE supplement to the IDE Document 
Mail Center (address above). IDE sponsors may submit this request for 
re-evaluation at any time, i.e., there is no time limit for submitting 
a reconsideration request to FDA. Further information about 
categorization, its effect on Medicare reimbursement, and appeal of a 
categorization determination, is contained in the September 19, 1995, 
final rule cited above.

    Dated: February 12. 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health
[FR Doc. 96-4066 Filed 2-22-96; 8:45 am]
BILLING CODE 4160-01-F