[Federal Register Volume 62, Number 76 (Monday, April 21, 1997)]
[Notices]
[Pages 19328-19337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10138]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-141-N]
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.
FOR FURTHER INFORMATION CONTACT:
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]]
SUPPLEMENTARY INFORMATION:
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
efficiently.
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/
pub6toc.htm.
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
H20.
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
Maintenance
Organizations; Correction.
08/01/96............... 40236-40242 ........................... BPO-139-N Medicare and Medicaid ........... ...........
Programs; Quarterly
Listing of Program
Issuances and Coverage
Decisions-First Quarter
1996.
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;
Correction.
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
Council.
09/19/96............... 49269-49271 401, 405 BPD-869-F Medicare Program; Waiver ........... 10/21/96
of Recovery of
Overpayments.
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
effectiveness.
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
categories:
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]
BILLING CODE 4120-01-P