[Federal Register Volume 61, Number 149 (Thursday, August 1, 1996)]
[Notices]
[Pages 40236-40242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19559]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-139-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances and Coverage Decisions--First 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, and
statements of policy that were published during January, February, and
March 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. Generally, we
also provide the content of revisions to the Medicare Coverage Issues
Manual. There were no revisions published during the period January 1
through March 31, 1996. On August 21, 1989, we published the content of
the Manual (54 FR 34555) and indicated that we will publish quarterly
any updates. Adding to this listing the complete text of the changes to
the Medicare Coverage Issues Manual fulfills this requirement in a
manner that facilitates identification of coverage and other changes in
our manuals.
FOR FURTHER INFORMATION CONTACT:
Margaret Cotton, (410) 786-5255 (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).
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, statements of policy, and guidelines
of general applicability not issued as regulations. We published our
first notice June 9, 1988 (53 FR 21730). 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. 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 January
through March 1996.
II. Medicare Coverage Issues
We receive numerous inquiries from the general public about whether
specific items or services are covered under Medicare. Providers,
carriers, and intermediaries have copies of the Medicare Coverage
Issues Manual, which identifies many of those medical items, services,
technologies, or treatment procedures that can be paid for under
Medicare. On August 21, 1989, we published a notice in the Federal
Register (54 FR 34555) that
[[Page 40237]]
contained all the Medicare coverage decisions issued in that manual.
In that notice, we indicated that revisions to the Coverage Issues
Manual will be published at least quarterly in the Federal Register. We
also sometimes issue proposed or final national coverage decision
changes in separate Federal Register notices. Readers should find this
an easy way to identify both issuance changes to all our manuals and
the text of changes to the Coverage Issues Manual.
Revisions to the Coverage Issues Manual are not published on a
regular basis but on an as-needed basis. We publish revisions as a
result of technological changes, medical practice changes, responses to
inquiries we receive seeking clarifications, or the resolution of
coverage issues under Medicare. If no Coverage Issues Manual revisions
were published during a particular quarter, our listing will reflect
that fact.
Not all revisions to the Coverage Issues Manual contain major
changes. As with any instruction, sometimes minor clarifications or
revisions are made within the text. This notice contains, as Addendum
IV, reprinted manual revisions as transmitted to manual holders. The
new text is shown in italics. We have not reprinted the table of
contents, since the table of contents serves primarily as a finding aid
for the user of the manual and does not identify items as covered or
not.
III. 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, coverage decisions, 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 identifies updates that changed
the Coverage Issues Manual. We published notices in the Federal
Register that included the text of changes to the Coverage Issues
Manual. These updates, when added to material from the manual published
on August 21, 1989 constitute a complete manual as of the end of the
quarter covered by this notice. Parties interested in obtaining a copy
of the manual and revisions should follow the instructions in section
IV of this notice.
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 sets forth the revisions to the Medicare Coverage
Issues Manual that were published during the quarter covered by this
notice. For the revisions, we give a brief synopsis of the revisions as
they appear on the transmittal sheet, the manual section number, and
the title of the section. We present a complete copy of the revised
material, no matter how minor the revision, and identify the revisions
by printing in italics the text that was changed. If the transmittal
includes material unrelated to the revised section, for example, when
the addition of revised material causes other sections to be
repaginated, we do not reprint the unrelated material.
Addendum V 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).
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 for which the notices cover.
IV. 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, ATTN: New
Order, 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.
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 24x 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) through the Internet and via asynchronous dial-in.
Internet users can access the database by using (1) the
[[Page 40238]]
World Wide Web--the Superintendent of Documents home page address is
http://www.access.gpo.gov/su__docs/; (2) local WAIS client software, or
(3) telnet--swais.access.gpo.gov, then login as guest (no password
required). Dial-in users should use communications software and modem
to call (202) 512-1661; type swais, then login as guest (no password
required). For general information about GPO Access, contact the GPO
Access User Support Team by sending Internet e-mail to help@eids05.eids; by faxing to (202) 512-1262; or by calling (202) 512-1530
between 7 a.m. and 5 p.m. Eastern time, Monday-Friday, except for
Federal holidays.
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.
V. 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 1400 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 Carriers Manual, Part 3--
Claims Process (HCFA-Pub. 14-3) transmittal entitled ``Beneficiary
Address Change,'' use the Superintendent of Documents No. HE 22.8/7 and
the HCFA transmittal number 1538.
VI. 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 Addenda III may be addressed
to Margaret Cotton, Bureau of Program Operations, Issuances Staff,
Health Care Financing Administration, S3-01-27, 7500 Security Blvd.,
Baltimore, MD 21244-1850, Telephone (410) 786-5255.
Questions concerning Medicaid items in Addenda 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
Blvd., 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, C5-09-05, 7500 Security Blvd.,
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: July 19, 1996.
Carol J. Walton,
Director, Bureau of Program Operations.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listing of program issuances and coverage decision updates to
the Coverage Issues Manual. For a complete listing of the quarterly
updates to the Coverage Issues Manual published during March 20, 1990
through November 14, 1994, please refer to the January 3, 1995 update
(60 FR 134).
January 3, 1995 (60 FR 132)
April 6, 1995 (60 FR 17538)
July 26, 1995 (60 FR 38344)
November 15, 1995 (60 FR 57435)
April 8, 1996 (61 FR 154)
June 26, 1996 (61 FR 33119)
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 40239]]
Addendum III--Medicare and Medicaid Manual Instructions January Through
March 1996
------------------------------------------------------------------------
Trans. No. Manual/Subject/Publication Number
------------------------------------------------------------------------
Intermediary Manual
Part 3--Claims Process (HCFA Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6-1)
------------------------------------------------------------------------
1671................... Claims Processing Terminology.
Handling Incomplete or Invalid Claims.
Data Element Requirements Matrix.
1672................... PRO Reporting on Medical Review.
1673................... Guidelines for Review of Claims for
Epoetin.
------------------------------------------------------------------------
Carriers Manual
Part 3--Claims Process (HCFA Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
1533................... Nomenclature and Organization of the
List.
Rebundling of CPT Codes.
Added ASC Codes.
1534................... Positron Emission Tomography Scans.
Billing Requirements for PET Scans.
Claims Processing Instructions for PET Scan
Claims.
1535................... Claims Processing Terminology.
Handling Incomplete or Invalid Claims.
Data Element Requirements Matrix.
Conditional Data Element Requirements.
1536................... Reasonableness and Necessity.
1537................... Item 24--Type of Service.
1538................... Beneficiary Address Change.
------------------------------------------------------------------------
Carriers Manual
Part 4--Professional Relations (HCFA Pub. 14-4)
(Superientendent of Documents No. HE 22.8/7-4)
------------------------------------------------------------------------
11..................... Items 1-13--Patient and Insured
Information.
Items 14-33--Physician or Supplier
Information.
Place of Service Codes and Definitions.
------------------------------------------------------------------------
Program Memorandum
Intermediaries/Carriers (HCFA Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
B-96-1................. Coverage for Occupational Therapists
in Independent Practice.
------------------------------------------------------------------------
Progam Memorandum
Carriers (HCFA Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
AB-96-1................ New Interest Rate Payable on Clean
Claims Not Paid Timely.
AB-96-2................ Exclusion Process, Sec. 1128(b)(7).
------------------------------------------------------------------------
Progam Memorandum
Insurance Commissioners (HCFA Pub. 80)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
96-1................... Medigap Bulletin Series (Number Five).
------------------------------------------------------------------------
Peer Review Organization
(HCFA Pub. 19)
(Superintendent of Documents No. HE 22.8/8-15)
------------------------------------------------------------------------
58..................... Background.
Beneficiary Hotline.
Interaction with Beneficiary Groups.
Other Activities.
59..................... PRO Reporting on Medical Review.
Tracking Adjustments.
PRO/Intermediary/Carrier Coordination
Activities.
Additional PRO/Carrier Coordination
Activities.
60..................... Background.
[[Page 40240]]
PRO Review Responsibilities.
Types of Prohibited Actions That Circumvent
PPS.
Actions to be Taken by PRO.
Authority.
Types of Denial Determinations.
Notification of Denial.
Content of Denial Notice.
Statutory and Regulatory Requirements.
Requests for Reconsideration.
Reconsideration Process.
Circumvention of Prospective Payment System.
Background.
Appeals Council Review.
Judicial Review.
Circumvention of PPS Denial Model Notice.
Circumvention of PPS Reconsideration Model
Notice.
61..................... Training.
Citations and Authority.
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Hospice Manual
(HCFA Pub. 21)
(Superintendent of Documents No. HE 22.8/18)
------------------------------------------------------------------------
47..................... Credit Balance Reporting Requirements.
Payment of Amounts Owed Medicare.
Medicare Credit Balance Report Certification.
Medicare Credit Balance Report (HCFA-838)
------------------------------------------------------------------------
Provider Reimbursement Manual
Part 1--(HCFA Pub.15-1)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
389.................... Travel Expense.
390.................... Regional Medicare Swing-Bed SNF Rates.
391.................... Interest.
Necessary.
Accounts Receivable Financing.
Costs Included in Capital-Related Costs.
Capital Related Costs of Related
Organizations.
Debt Issuance Costs, Debt Discounts, and Debt
Redemption Costs.
Costs Excluded From Capital-Related Costs.
Jointly Owned Equipment.
Unpaid Compensation.
392.................... Ambulance Service.
------------------------------------------------------------------------
Medicare/Medicaid
Sanction--Reinstatement Report
(HCFA Pub. 69)
------------------------------------------------------------------------
96-1................... Cumulative Report of Physicians/
Practitioners, Providers and/or Other Health
Care Suppliers Sanctioned/Reinstated.
96-2................... Report of Physicians/Practioners,
Providers and/or Other Health Care Suppliers
Excluded/Reinstated--December 1995 and January
1996.
96-3................... Report of Physicians/Practitioners,
Providers and/or Other Health Care Suppliers/
Reinstated--February 1996.
------------------------------------------------------------------------
Addendum IV
There are no revisions to the Coverage Issues Manual for this
quarter.
Addendum V.--Regulation Documents Published in the Federal Register
----------------------------------------------------------------------------------------------------------------
End of
Publication date FR Vol. 61 CFR Part File code * Regulation comment Effective
page title period date
----------------------------------------------------------------------------------------------------------------
01/19/96......... 1389-1390 ................ BPD-854-NC Medicare and 03/19/96 01/19/96
Medicaid
Programs;
Announcement
of
Applications
from Hospitals
Requesting
Waivers for
Organ
Procurement
Service Area.
01/23/96......... 1769-1772 ................ ORD-083-N New and Pending ........... ...........
Demonstration
Project
Proposals
Submitted
Pursuant to
Section
1115(a) of the
Social
Security Act:
November 1995.
[[Page 40241]]
01/26/96......... 2516-2519 ................ BPO-134-NC Medicare 02/26/96 02/01/96
Program;
Revised
Criteria and
Standards for
Evaluating
Durable
Medical
Equipment,
Prosthetics,
Orthotics, and
Supplies
Regional
Carriers'
Performance
Beginning
February 1,
1996.
01/26/96......... 2516 ................ ORD-078-N Medicare ........... ...........
Program;
Announcement
of Funding
Availability
for a
Cooperative
Agreement for
an End-Stage
Renal Disease
(ESRD) Managed
Care
Demonstration.
01/29/96......... 2725-2727 412, 413........ BPD-825-FCN Medicare ........... 10/01/95
Program;
Changes to the
Hospital
Inpatient
Prospective
Payment
Systems and
Fiscal Year
1996 Rates;
Corrections.
02/27/96......... 7266 ................ ORD-084-N New and Pending ........... ...........
Demonstration
Project
Proposals
Submitted
Pursuant to
Section
1115(a) of the
Social
Security Act:
December 1995.
02/29/96......... 7798 ................ ORD-085-N New and Pending ........... ...........
Demonstration
Project
Proposals
Submitted
Pursuant to
Section
1115(a) of the
Social
Security Act:
January 1996.
03/08/96......... 9405-9410 440............. MB-071-P Medicare 05/07/96 ...........
Program;
Coverage of
Personal Care
Services.
03/27/96......... 13430-1345 417,434......... OMC-010-FC Medicare and 05/28/96 04/26/96
0 Medicaid
Programs;
Requirements
for Physician
Incentive
Plans in
Prepaid Health
Care
Organizations.
----------------------------------------------------------------------------------------------------------------
* GN--General Notice; PN--Proposed Notice; FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final
Rule; FC--Final Rule with Comment Period; CN--Correction Notice; SN--Suspension Notice; WN--Withdrawal Notice;
NR--Notice of HCFA Ruling.
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 (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 modification 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. G950168 A2, G950175 A1, G960026 A2,
G960033 A1, G960034 A1, G960055 A2, G960060 A1, G960066 A2
The following information presents the device number, category (in
this case, B), and criterion code. G950194 B1, G950210 B1, G950212 B3,
G950217 B1, G950218 B1, G950229 B3, G950231 B, G960003 B4, G960018 B4,
G960019 B4, G960021 B2, G960022 B4, G960023 B2, G960024 B3, G960025 B2,
G960027 B4, G960028 B1, G960029 B4, G960030 B2, G960031 B2, G960035 B4,
G960037 B4, G960038 B4, G960041 B4, G960043
[[Page 40242]]
B1, G960046 B1, G960051 B3, G960054 B3, G960056 B5, G960057 B2, G960059
B2, G960061 B2, G960062 B2
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. 96-19559 Filed 7-31-96; 8:45 am]
BILLING CODE 4120-01-P
