[Federal Register Volume 62, Number 76 (Monday, April 21, 1997)]
[Pages 19328-19337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10138]



Health Care Financing Administration

Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--Third Quarter 1996

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.


SUMMARY: This notice lists HCFA manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published during July, August, and September of 1996 that relate to the 
Medicare and Medicaid programs. It also identifies certain devices with 
investigational device exemption numbers approved by the Food and Drug 
Administration that may be potentially covered under Medicare.
    Section 1871(c) of the Social Security Act requires that we publish 
a list of Medicare issuances in the Federal Register at least every 3 
months. Although we are not mandated to do so by statute, for the sake 
of completeness of the listing, we are including all Medicaid issuances 
and Medicare and Medicaid substantive and interpretive regulations 
(proposed and final) published during this time frame.


Bridget Wilhite, (410) 786-5248 (For Medicare instruction information).
Pat Prete, (410) 786-3246 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Cathy Johnson, (410) 786-5241 (For all other information).

[[Page 19329]]


I. Program Issuances

    The Health Care Financing Administration (HCFA) is responsible for 
administering the Medicare and Medicaid programs, which pay for health 
care and related services for 38 million Medicare beneficiaries and 36 
million Medicaid recipients. Administration of these programs involves 
(1) Providing information to Medicare beneficiaries and Medicaid 
recipients, health care providers, and the public, and (2) effective 
communications with regional offices, State governments, State Medicaid 
Agencies, State Survey Agencies, various providers of health care, 
fiscal intermediaries and carriers that process claims and pay bills, 
and others. To implement the various statutes on which the programs are 
based, we issue regulations under the authority granted the Secretary 
under sections 1102, 1871, and 1902 and related provisions of the 
Social Security Act (the Act) and also issue various manuals, 
memoranda, and statements necessary to administer the programs 
    Section 1871(c)(1) of the Act requires that we publish in the 
Federal Register at least every 3 months a list of all Medicare manual 
instructions, interpretive rules, and guidelines of general 
applicability not issued as regulations. We published our first notice 
June 9, 1988 (53 FR 21730).
    Since the publication of our quarterly listing on June 12, 1992 (57 
FR 24797), we decided to add Medicaid issuances to our quarterly 
listings. Accordingly, we list in this notice Medicaid issuances and 
Medicaid substantive and interpretive regulations published during July 
through September 1996.
    Although we are not mandated to do so by statute, for the sake of 
completeness of the listing of operational and policy statements, we 
are continuing our practice of including Medicare substantive and 
interpretive regulations (proposed and final) published during the 3-
month time frame and are initiating the inclusion of HCFA Rulings.

II. How To Use the Addenda

    This notice is organized so that a reader may review the subjects 
of all manual issuances, memoranda, substantive and interpretive 
regulations, or Food and Drug Administration-approved investigational 
device exemptions published during the time frame to determine whether 
any are of particular interest. We expect it to be used in concert with 
previously published notices. Most notably, those unfamiliar with a 
description of our Medicare manuals may wish to review Table I of our 
first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) and the 
notice published March 31, 1993 (58 FR 16837), and those desiring 
information on the Medicare Coverage Issues Manual may wish to review 
the August 21, 1989 publication (54 FR 34555).
    To aid the reader, we have organized and divided this current 
listing into six addenda. Addendum I lists the publication dates of the 
most recent quarterly listing of program issuances.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published HCFA Medicare and 
Medicaid manuals and memoranda.
    Addendum III of this notice lists, for each of our manuals or 
Program Memoranda, a HCFA transmittal number unique to that instruction 
and its subject matter. A transmittal may consist of a single 
instruction or many. Often it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
    Addendum IV lists all substantive and interpretive Medicare and 
Medicaid regulations and general notices published in the Federal 
Register during the quarter covered by this notice. For each item, we 
list the date published, the Federal Register citation, the parts of 
the Code of Federal Regulations (CFR) that have changed (if 
applicable), the agency file code number, the title of the regulation, 
the ending date of the comment period (if applicable), and the 
effective date (if applicable).
    Addendum V lists a HCFA Ruling that was issued during the period 
covered by this notice. A HCFA ruling which is a statement of policy or 
interpretation that has not been published in the Federal Register as 
part of a regulation or of a notice implementing regulations, but which 
has been adopted by HCFA as having precedent.
    On September 19, 1995, we published a final rule (60 FR 48417) 
establishing in regulations that certain devices with an 
investigational device exemption approved by the Food and Drug 
Administration and certain services related to those devices may be 
covered under Medicare. That final rule states that we will announce in 
this quarterly notice all investigational device exemption 
categorizations, using the investigational device exemption numbers the 
Food and Drug Administration assigns. Addendum VI includes listings of 
the Food and Drug Administration-approved investigational device 
exemption numbers that have been approved during the quarter covered by 
this notice. The listings are organized according to the categories to 
which the device numbers are assigned (that is, Category A or Category 
B, and identified by the investigational device exemption number). 
Future notices will announce investigational device exemption 
categorizations and the numbers assigned by the Food and Drug 
Administration for the quarter covered by the notice.

III. How To Obtain Listed Material

A. Manuals

    An individual or organization interested in routinely receiving any 
manual and revisions to it may purchase a subscription to that manual. 
Those wishing to subscribe should contact either the Government 
Printing Office (GPO) or the National Technical Information Service 
(NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, A TTN: New 
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 
512-1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825 
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell. 
Additionally, all manuals are available at the following Internet 
address: http//www.hcfa.gov/pubforms/progman.htm.

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the address 
given above. When ordering individual copies, it is necessary to cite 
either the date of publication or the volume number and page number.
    The Federal Register is also available on 24 x  microfiche and as 
an online database through GPO Access. The online database is updated 
by 6 a.m. each day the Federal Register is published. The database 
includes both text and graphics from Volume 59, Number 1 (January 2, 
1994) forward. Free public access is available on a Wide Area 
Information Server (WAIS)

[[Page 19330]]

through the Internet and via asynchronous dial-in. Internet users can 
access the database by using the World Wide Web; the Superintendent of 
Documents home page address is http://www.access.gpo.gov/su__docs/, by 
using local WAIS client software, or by telnet to swais.access.gpo.gov, 
then log in as guest (no password required). Dial-in users should use 
communications software and modem to call (202) 512-1661; type swais, 
then log in as guest (no password required).

C. Rulings

    We publish Rulings on an infrequent basis. Interested individuals 
can obtain copies from the nearest HCFA Regional Office or review them 
at the nearest regional depository library. We also sometimes publish 
Rulings in the Federal Register.

D. HCFA's Compact Disk-Read Only Memory (CD-ROM)

    Our laws, regulations, and manuals are also available on CD-ROM, 
which may be purchased from GPO or NTIS on a subscription or single 
copy basis. The Superintendent of Documents list ID is HCLRM, and the 
stock number is 717-139-00000-3. The following material is on the CD-
ROM disk:
     Titles XI, XVIII, and XIX of the Act.
     HCFA-related regulations.
     HCFA manuals and monthly revisions.
     HCFA program memoranda.
    The titles of the Compilation of the Social Security Laws are 
current as of January 1, 1995. The remaining portions of CD-ROM are 
updated on a monthly basis.
    Because of complaints about the unreadability of the Appendices 
(Interpretive Guidelines) in the State Operations Manual (SOM), as of 
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future, and, with the aid of newer 
technology, we may again be able to include the appendices on CD-ROM.
    Any cost report forms incorporated in the manuals are included on 
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the 
reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local 
Federal Depository Library (FDL). Under the FDL program, government 
publications are sent to approximately 1,400 designated libraries 
throughout the United States. Interested parties may examine the 
documents at any one of the FDLs. Some may have arrangements to 
transfer material to a local library not designated as an FDL. To 
locate the nearest FDL, contact any library.
    In addition, individuals may contact regional depository libraries, 
which receive and retain at least one copy of most Federal government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library. Superintendent of Documents 
numbers for each HCFA publication are shown in Addendum III, along with 
the HCFA publication and transmittal numbers. To help FDLs locate the 
instruction, use the Superintendent of Documents number, plus the HCFA 
transmittal number. For example, to find the Intermediary Manual, Part 
1--Fiscal Administration (HCFA Pub. 13-1) transmittal entitled 
``Electronic Remittance Advice,'' use the Superintendent of Documents 
No. HE 22.8/6-3 and the HCFA transmittal number 127.

V. General Information

    It is possible that an interested party may have a specific 
information need and not be able to determine from the listed 
information whether the issuance or regulation would fulfill that need. 
Consequently, we are providing information contact persons to answer 
general questions concerning these items. Copies are not available 
through the contact persons. Copies can be purchased or reviewed as 
noted above.
    Questions concerning Medicare items in Addendum III may be 
addressed to Bridget Wilhite, Bureau of Program Operations, Issuances 
Staff, Health Care Financing Administration, N2-05-03, 7500 Security 
Boulevard, Baltimore, 21244-1850, Telephone (410) 786-5248.
    Questions concerning Medicaid items in Addendum III may be 
addressed to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, 
Health Care Financing Administration, C4-25-02, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-3246.
    Questions concerning Food and Drug Administration-approved 
investigational device exemptions may be addressed to Sharon Hippler, 
Bureau of Policy Development, Office of Chronic Care and Insurance 
Policy, Health Care Financing Administration, C4-11-04, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633.
    Questions concerning all other information may be addressed to 
Cathy Johnson, Bureau of Policy Development, Office of Regulations, 
Health Care Financing Administration, C5-12-16, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-5241.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)

    Dated: April 10, 1997.
Gary Kavanagh,
Acting Director, Bureau of Program Operations.

Addendum I

    This addendum lists the publication dates of the most recent 
quarterly listings of program issuances.

July 26, 1995 (60 FR 38344)
November 15, 1995 (60 FR 57435)
April 8, 1996 (61 FR 15491)
June 26, 1996 (61 FR 33119)
December 18, 1996 (61 FR 66676)

Addendum II.--Description of Manuals, Memoranda, and HCFA Rulings

    An extensive descriptive listing of Medicare manuals and memoranda 
was published on June 9, 1988, at 53 FR 21730 and supplemented on 
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 
50577. Also, a complete description of the Medicare Coverage Issues 
Manual was published on August 21, 1989, at 54 FR 34555. A brief 
description of the various Medicaid manuals and memoranda that we 
maintain was published on October 16, 1992, at 57 FR 47468.

[[Page 19331]]

                             Addendum III--Medicare and Medicaid Manual Instructions                            
                                          [July through September 1996]                                         
          Trans. No.                                      Manual/Subject/Publication Number                     
                                               Intermediary Manual                                              
                                 Part 1--Fiscal Administration (HCFA Pub. 13-1)                                 
                                  (Superintendent of Documents No. HE 22.8/6-3)                                 
127                             http://www.hcfa.gov/pubforms/pub6/
Transmittal No. 88
    Clarification--Effective Date: Not Applicable.
    Section 50-41, Human Tumor Stem Cell Drug Sensitivity Assays, 
clarifies that while the fluorescent cytoprint assay (FCA) is not based 
upon the same or a similar procedure as the human tumor stem cell drug 
sensitivity assay, it is sufficiently alike that it is included under 
this subject. The basic difference is that the FCA incorporates the use 
of microorgan systems and a fluorescent dye. The test is performed as 
an in vitro chemosensitivity test for the effectiveness of drugs for 
cancer treatment. Medicare considers the clinical application of this 
procedure as experimental and not covered by the program at this time.
Transmittal No. 89
    Changed Implementing Instructions--Effective Date: For services 
furnished on or after 10/07/96.

[[Page 19335]]

    Section 65-9, Incontinence Control Devices, is revised to reflect 
that in female patients the Abdominal Leak Point Pressure (ALPP) 
measurement is amended from less than 65 cm H20 to an ALPP of less 
than 100 cm HH20, if the diagnosis of intrinsic sphincter 
deficiency (ISD) is established. HCFA is amending the leak point 
pressure measurement in female patients without urethral hypermobility 
and with abdominal leak point pressures of 65 cm H20 to 100 cm 
    For patients whose incontinence showed no improvement after the 
initial five treatments, no further treatments are covered. HCFA is 
amending the lifetime limitation of five treatment sessions for 
patients who have received successful treatments in the past to allow 
latitude for the treating physician to decide whether additional 
sessions of collagen injection may be beneficial. For these patients, 
medical documentation must accompany claims for additional treatments 
beyond five. HCFA is deleting the requirement that patients must have 
shown no improvement in their incontinence for at least 12 months prior 
to collagen therapy in order to be eligible for coverage.
    In addition, the coverage guidelines for pelvic floor stimulators 
that were previously in Sec. 65-11 under the bladder stimulators policy 
are being moved to Sec. 65-9 since pelvic floor stimulators are more 
appropriately identified as incontinence control devices. Section 65-9 
is also revised to indicate that pelvic floor stimulators are not 
covered for the reason that the effectiveness of these devices is 
unproven. The previous policy in Sec. 65-11 indicated that both the 
safety and effectiveness of pelvic floor stimulators were unproven.
    Section 65-11, Bladder Stimulators, is revised to eliminate the use 
of name brand products. HCFA now identifies devices according to a 
general categorization of products rather than by specific brand names. 
In addition, the coverage guidelines for pelvic floor stimulators have 
been moved to Sec. 65-9.

                                          Addendum IV.--Regulation Documents Published in the Federal Register                                          
                                                                                                                                   End of               
    Publication date     FR vol. 61 page          CFR part(s)                   File code*               Regulation title         comment     Effective 
                                                                                                                                   period        date   
07/01/96...............      33928-33936  ...........................  BPD-847-CN                   Medicare Program; Changes   ...........  ...........
                                                                                                     to the Hospital Inpatient                          
                                                                                                     Prospective Payment                                
                                                                                                     Systems and Fiscal Year                            
                                                                                                     1997 Rates; Correction.                            
07/01/96...............      34344-34365  ...........................  BPD-867-NC                   Medicare Program; Schedule     08/30/96       070196
                                                                                                     of Limits on Home Health                           
                                                                                                     Agency Costs Per Visit                             
                                                                                                     for Cost Reporting                                 
                                                                                                     Periods Beginning on or                            
                                                                                                     After July 1, 1996.                                
07/02/96...............      34614-34662  405, 410, 415                BPD-852-P                    Medicare Program;              09/03/96  ...........
                                                                                                     Revisions to Payment                               
                                                                                                     Policies Under the                                 
                                                                                                     Physician Fee Schedule                             
                                                                                                     for Calendar Year 1997.                            
07/05/96...............            35307  405, 417, 431, 473, 498      BPD-704-FC                   Medicare and Medicaid       ...........     07/24/96
                                                                                                     Programs; Provider                                 
                                                                                                     Appeals; Technical                                 
                                                                                                     Amendments; Correction.                            
07/16/96...............      37011-37015  413                          BPD-647-F                    Medicare Program;           ...........     08/15/96
                                                                                                     Reporting of Interest                              
                                                                                                     From Zero Coupon Bonds.                            
07/23/96...............      38207-38212  ...........................  BPD-849-PN                   Medicare Program;              08/22/96  ...........
                                                                                                     Recognition of the                                 
                                                                                                     Ambulatory Surgical                                
                                                                                                     Center Standards of the                            
                                                                                                     Joint Commission on the                            
                                                                                                     Accreditation of                                   
                                                                                                     Healthcare Organizations                           
                                                                                                     and the Accreditation                              
                                                                                                     Association for                                    
                                                                                                     Ambulatory Health Care.                            
07/24/96...............      38395-38399  ...........................  MB-099-F                     Medicaid Program; Medicaid  ...........     08/23/96
                                                                                                     Eligibility Quality                                
                                                                                                     Control, Progressive                               
                                                                                                     Reductions in Federal                              
                                                                                                     Financial Participation                            
                                                                                                     for FYs 1982-1984,                                 
                                                                                                     Payment for Physician                              
                                                                                                     Billing for Clinical                               
                                                                                                     Laboratory Services, and                           
                                                                                                     Utilization Control of                             
                                                                                                     Skilled Nursing Facility                           
                                                                                                     Services: Removal of                               
                                                                                                     Obsolete Requirements.                             
07/24/96...............            38395  417                          OMC-009-FC                   Medicare Program;           ...........     10/01/95
                                                                                                     Qualified Health                                   
                                                                                                     Organizations; Correction.                         
08/01/96...............      40236-40242  ...........................  BPO-139-N                    Medicare and Medicaid       ...........  ...........
                                                                                                     Programs; Quarterly                                
                                                                                                     Listing of Program                                 
                                                                                                     Issuances and Coverage                             
                                                                                                     Decisions-First Quarter                            
08/02/96...............      40343-40347  406, 407, 408, 416           BPD-752-FC                   Medicare Program; Special      10/01/96     09/03/96
                                                                                                     Enrollment Periods and                             
                                                                                                     Waiting Period.                                    
08/15/96...............      42385-42386  417, 473, 498                BPD-704-CN                   Medicare and Medicaid       ...........     07/24/96
                                                                                                     Programs: Provider                                 
                                                                                                     Appeals; Technical                                 
                                                                                                     Amendments; Corrections.                           
08/15/96...............            42385  415                          BPD-827-CN                   Medicare Program;           ...........   \1\ 01/01/
                                                                                                     Revisions to Payment                             96
                                                                                                     Policies and Adjustments                           
                                                                                                     to the Relative Value                              
                                                                                                     Units Under the Physician                          
                                                                                                     Fee Schedule for Calendar                          
                                                                                                     Year 1996; Correction.                             

[[Page 19336]]

08/16/96...............      42637-42638  ...........................  ORD-090-N                    New and Pending             ...........  ...........
                                                                                                     Demonstration Project                              
                                                                                                     Proposals Submitted                                
                                                                                                     Pursuant to Section                                
                                                                                                     1115(a) of the Social                              
                                                                                                     Security Act: June 1996.                           
08/30/96...............      46166-46328  412, 413, 489                BPD-847-F                    Medicare Program; Changes   ...........     10/01/96
                                                                                                     to the Hospital Inpatient                          
                                                                                                     Prospective Payment                                
                                                                                                     Systems and Fiscal Year                            
                                                                                                     1997 Rates.                                        
09/03/96...............      46466-46478  ...........................  BPD-842-NC                   Medicare Program; Schedule     11/04/96     10/01/96
                                                                                                     of Prospectively                                   
                                                                                                     Determined Payment Rates                           
                                                                                                     for Skilled Nursing                                
                                                                                                     Facility Inpatient                                 
                                                                                                     Routine Service Costs.                             
09/03/96...............      46384-46385  417                          OMC-010-FC                   Medicare and Medicaid          11/04/96     09/03/96
                                                                                                     Programs; Requirements                             
                                                                                                     for Physician Incentive                            
                                                                                                     Plans in Prepaid Health                            
                                                                                                     Care Organizations;                                
09/04/96...............      46579-46603  418                          BPD-820-P                    Medicare Program; Hospice      11/04/96  ...........
                                                                                                     Wage Index.                                        
09/09/96...............      47423-47434  482                          BPD-633-F                    Medicare and Medicaid       ...........     11/08/96
                                                                                                     Program; Hospital                                  
                                                                                                     Standard for Potentially                           
                                                                                                     HIV Infectious Blood and                           
                                                                                                     Blood Products.                                    
09/11/96...............      47946-47950  ORD-091-N                    New and Pending              ..........................  ...........             
                                                                        Demonstration Project                                                           
                                                                        Proposals Submitted                                                             
                                                                        Pursuant to Section                                                             
                                                                        1115(a) of the Social                                                           
                                                                        Security Act                                                                    
09/11/96...............      47950-47951  ...........................  OPL-011-N                    Medicare Program;           ...........  ...........
                                                                                                     September 30, 1996                                 
                                                                                                     Meeting of the Practicing                          
                                                                                                     Physicians Advisory                                
09/19/96...............      49269-49271  401, 405                     BPD-869-F                    Medicare Program; Waiver    ...........     10/21/96
                                                                                                     of Recovery of                                     
09/19/96...............      49271-49276  421                          BPO-105-F                    Medicare Program; Part B    ...........     10/21/96
                                                                                                     Advance Payments to                                
                                                                                                     Suppliers Furnishing                               
                                                                                                     Items or Services Under                            
                                                                                                     Medicare Part B.                                   
09/23/96...............      49781-49785  ...........................  MB-100-N                     Medicaid Program; Final     ...........  ...........
                                                                                                     Limitations on Aggregate                           
                                                                                                     Payments to                                        
                                                                                                     Disproportionate Share                             
                                                                                                     Hospitals; Federal Fiscal                          
                                                                                                     Year 1996.                                         
09/26/96...............            50493  ...........................  ORD-092-N                    New and Pending                                     
                                                                                                     Demonstration Project                              
                                                                                                     Proposals Submitted                                
                                                                                                     Pursuant to Section                                
                                                                                                     1115(a) of the Social                              
                                                                                                     Security Act: August 1996.                         
09/30/96...............            51021  ...........................  BPD-704-CN                   Medicare and Medicaid       ...........     07/24/96
                                                                                                     Programs; Provider                                 
                                                                                                     Appeals: Technical                                 
                                                                                                     Amendments; Correction.                            
\1\ And 07/01/96 (part 415 only).                                                                                                                       

Addendum V.--HCFA Ruling

    HCFAR-96-1 Medicare Program; Medicare Supplementary Medical 
Insurance (Part B); Clarification of the Terms ``Orthotics,'' 
``Braces,'' and ``Durable Medical Equipment'' under Medicare Part B. 
Issued September 18, 1996.

Addendum VI.--Categorization of Food and Drug Administration-Approved 
Investigational Device Exemptions

    Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices 
fall into one of three classes:
    Class I--Devices for which the general controls of the Food, Drug, 
and Cosmetic Act, such as adherence to good manufacturing practice 
regulations, are sufficient to provide a reasonable assurance of safety 
and effectiveness.
    Class II--Devices that, in addition to general controls, require 
special controls, such as performance standards or postmarket 
surveillance, to provide a reasonable assurance of safety and 
    Class III--Devices that cannot be classified into Class I or Class 
II because insufficient information exists to determine that either 
special or general controls would provide reasonable assurance of 
safety and effectiveness. Class III devices require premarket approval.
    Under the new categorization process to assist HCFA, the Food and 
Drug Administration assigns each device with a Food and Drug 
Administration-approved investigational device exemption to one of two 
    Experimental/Investigational (Category A) Devices, or Non-
Experimental/Investigational (Category B) Devices. Under this 
categorization process, an experimental/investigational

[[Page 19337]]

(Category A) device is an innovative device 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 Food and Drug Administration is unsure whether the device type 
can be safe and effective). A non-experimental/investigational 
(Category B) device is a device believed to be in Class I or Class II, 
or a device believed to be in Class III for which the incremental risk 
is the primary risk in question (that is, underlying questions of 
safety and effectiveness of that 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 Food and Drug Administration 
approval for that device type. The criteria the Food and Drug 
Administration uses to categorize an investigational device under 
Category B include the following:
    (1) Devices, regardless of the classification, under investigation 
to establish substantial equivalence to a predicate device, that is, to 
establish substantial equivalence to a previously/currently legally 
marketed device.
    (2) Class III devices whose technological characteristics and 
indication for use are comparable to a Pre-Market Approval (PMA)-
approved device.
    (3) Class III devices with technological advances compared to a 
PMA-approved device, that is, a device with technological changes that 
represent advances to a device that has already received PMA-approval 
(generational changes).
    (4) Class III devices that are comparable to a PMA-approved device 
but are under investigation for a new indication for use. For purposes 
of studying the new indication, no significant modifications to the 
device were required.
    (5) Pre-amendments Class III devices that become the subject of an 
investigational device exemption after the Food and Drug Administration 
requires premarket approval, that is, no PMA application was submitted 
or the PMA application was denied.
    (6) Nonsignificant risk device investigations for which the Food 
and Drug Administration required the submission of an investigational 
device exemption.
    The following information presents the device number, category (in 
this case, A), and criterion code.

G960032  A1
G960055  A
G960069  A2
G960125  A1
G960140  A2
G960143  A2
G960154  A2
G960169  A2
    The following information presents the device number category (in 
this case,  B), and criterion code.

G940026  B
    G950128  B3
    G960005  B1
    G960022  B2
    G960050  B2
    G960059  B2
    G960077  B3
    G960080  B3
    G960092  B4
    G960114  B4
    G960116  B4
    G960117  B2
    G960120  B1
    G960121  B3
    G960122  B2
    G960123  B1
    G960126  B2
    G960127  B4
    G960128  B1
    G960129  B3
    G960130  B
    G960132  B4
    G960133  B2
    G960135  B1
    G960136  B2
    G960139  B4
    G960141  B
    G960142  B2
    G960148  B
    G960150  B2
    G960151  B4
    G960152  B4
    G960153  B2
    G960155  B1
    G960156  B
    G960157  B
    G960158  B4
    G960159  B
    G960161  B
    G960162  B
    G960165  B
    G960168  B1
    G960170  B4
    G960171  B3
    G960172  B3
    G960173  B
    G960175  B2
    G960176  B1
    G960177  B3
    G960179  B1
    G960180  B4
    G960182  B2
    G960221  B4
    Note: Some investigational devices may exhibit unique 
characteristics or raise safety concerns that make additional 
consideration necessary. For these devices, HCFA and the Food and 
Drug Administration will agree on the additional criteria to be 
used. The Food and Drug Administration will use these criteria to 
assign the device(s) to a category. As experience is gained in the 
categorization process, this addendum may be modified.

[FR Doc. 97-10138 Filed 4-18-97; 8:45 am]