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Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) (Text Only)

Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices
September 15, 1995 (D95-2)

 


IDE Guidance Memorandum #95-2

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

   
       Office of Device Evaluation (HFZ-400)
       
       Implementation of the FDA/HCFA Interagency Agreement Regarding 
       Reimbursement Categorization of Investigational Devices
         
       ODE Review Staff
         
         
       Purpose
         
       The purpose of this memorandum is to establish procedures for 
       fulfilling FDA's responsibilities as defined in the FDA/HCFA 
       Interagency Agreement (IA) pertaining to the reimbursement of 
       investigational devices.
        
       Background
         
       According to the statute governing the Medicare program (Section 1862 
       (a)(1)(A) of the Social Securities Act), the Health Care Financing 
       Administration (HCFA) is permitted to reimburse for medical services 
       and products that are deemed "reasonable and necessary" for the 
       diagnosis or treatment of an illness or injury, or to improve the 
       functioning of a malformed body member.  The Medicare program has 
       historically interpreted the statutory terms "reasonable and necessary" 
       to mean that a service or medical device must be safe and effective, 
       medically necessary and appropriate, and not experimental in order to 
       qualify for reimbursement.  For Medicare coverage purposes, the term 
       "experimental" has been used synonymously with the term 
       "investigational."  Therefore, with rare exception, an FDA-approved 
       Investigational Device Exemption (IDE) application served as an 
       indication that the device was not "reasonable and necessary" within 
       the meaning of the Medicare program.  Thus, Medicare coverage was 
       denied for devices which were under an IDE and had not yet received 
       premarket notification clearance and or premarket approval.
         
       There is increasing recognition, however, that there are devices which 
       are refinements of existing technologies or replications of existing 
       technologies made by other manufacturers.  Many of these devices are 
       under an FDA-approved IDE as a means of gathering the scientific 
       information needed for FDA to establish the safety and effectiveness of 
       that particular device, even though there is evidence that the device 
       type can be safe and effective.  Such devices could be viewed as 
       "reasonable and necessary" by Medicare and thus be reimbursed if it 
       were possible to identify these devices to HCFA.
         
       On September 8, 1995, FDA and HCFA entered into an Interagency 
       Agreement (See Attachment A) pursuant to which FDA agreed to institute 
       a procedure for providing certain information to HCFA to aid in its 
       reimbursement decisions.  The information supplied to HCFA will be used 
       in determining whether sufficient information exists concerning the 
       safety and effectiveness of the investigational device to permit 
       reimbursement under the Medicare program.  Specifically, FDA will 
       inform HCFA whether the clinical evaluation of an investigational 
       device falls into one of two categories. 
         
       Those investigations involving innovative devices believed to be in 
       Class III for which "absolute risk" of the device type has not been 
       established (i.e., initial questions of safety and effectiveness have 
       not been resolved and thus FDA is unsure whether the device type can be 
       safe and effective) will be assigned to Category A.  Devices believed 
       to be in Classes I or II or devices believed to be in Class III where 
       the incremental risk is the primary risk in question (i.e., underlying 
       questions of safety and effectiveness of that device type have been 
       resolved) will be assigned to Category B.  Thus, Category B includes 
       those device types known to be safe and effective because, for example, 
       other manufacturers have obtained FDA approval/clearance for that 
       device type.  The precise criteria to be used by FDA in assigning IDEs 
       to these reimbursement categories are set forth in the Interagency 
       Agreement. 
         
       This interagency effort is an important initiative which will 
       significantly impact both patient care and the development of new 
       medical technology.  By expanding the Medicare coverage policy to 
       include certain investigational devices,  Medicare beneficiaries will 
       be assured greater access to the latest advancement in medical 
       technology.  In addition, the revision of the reimbursement policy to 
       include investigational devices may help to improve the quality of 
       clinical studies by ensuring that the Medicare patient population is 
       included in the investigations and thus the devices are being tested on 
       the appropriate patient population.  Finally, it is anticipated that 
       this change in policy will help to facilitate patient enrollment into 
       clinical trials.  Implementation of FDA's responsibilities as defined 
       in the Interagency Agreement will help attain these important goals.  
         
       Procedures
         
       Below, the procedures to be used by ODE staff in order to fulfill FDA's 
       responsibilities in the Interagency Agreement are described.  
       Implementation of the IA will involve two phases.  In phase I, all IDE 
       applications that are either approved, conditionally approved, or 
       deemed approved (unless deemed approved and immediately withdrawn) by 
       September 15, 1995 will be assigned to one of the two reimbursement 
       categories as described in the Interagency Agreement.  Phase II of the 
       process will begin on September 18, 1995.   On this date, each 
       reviewing division, as a routine part of the IDE review process, will 
       assume responsibility for implementing the reimbursement categorization 
       process for all IDEs that are received on or after that date.  Each of 
       these phases is discussed in detail below.
         
       A.  Phase I: Categorization of Approved IDEs
         
       Using the criteria defined in the attachment of the Interagency 
       Agreement, the divisions will be responsible for categorizing all IDEs 
       which are approved ("full", conditional, or deemed) by September 15, 
       1995.  A special training session will be conducted by ODE senior 
       management and the IDE staff during which guidance on the 
       categorization determination process will be provided to division 
       supervisors (branch chiefs and associate/deputy division directors).  

       In most instances, it will be possible to categorize the 
       investigational device based on data available in the IDE database; 
       however, in some instances, it may be necessary to refer to the actual 
       IDE application as well as information regarding similar marketed 
       devices.  It is anticipated that the vast majority of devices will be 
       assigned to Category B (i.e., Non-experimental/Investigational).  The 
       data on reimbursement categorization will be compiled and forwarded to 
       HCFA on or before November 1, 1995.  Therefore, the categorization of 
       all IDEs approved by September 15, 1995 must be completed and forwarded 
       to the IDE staff no later than October 6, 1995.  
         
       The IDE staff will provide the divisions with a list of all IDE 
       applications which must be categorized.  This will include only those 
       IDEs in the database which are approved.  IDEs which have been 
       terminated will be considered exempt from this IA agreement and thus 
       will not be assigned to a reimbursement category.  The IDE staff will 
       also provide ODE's reviewing divisions with a standardized form to 
       allow the information to be captured in a uniform fashion. IDE staff 
       consultation and concurrence is required for any IDE application which 
       is assigned to Category A (i.e., Experimental).  (The boilerplate 
       checklist (Document H-1 on the LAN) which identifies the rationale for 
       this categorization determination must be signed-off by both division 
       management and the IDE staff.  Also see Attachment B)
         
       In order to make this information publicly available, the Division of 
       Small Manufacturers Assistance (DSMA) will post on its electronic 
       docket a list of the approved IDEs (IDE numbers only) and the 
       corresponding reimbursement category.
         
       B.  Phase II:  IDEs Approved after September 15, 1995
         
       On September 18, 1995, the divisions will become responsible for 
       determining the reimbursement categorization for those IDEs which are 
       approved, conditionally approved, or deemed approved (unless deemed 
       approved and immediately withdrawn).  As previously noted, it is 
       anticipated that in most instances categorization will be possible on 
       the basis of a quick review of the division's records and the IDE 
       database.  As discussed above, for those cases where an IDE is assigned 
       to Category A, the branch chief must contact the IDE staff prior to 
       issuing the approval letter or otherwise notifying the sponsor or HCFA 
       of this categorization decision.  The IDE staff will review the 
       decision and notify the division of its concurrence.
         
       IDE boilerplate approval letters ("full", conditional, and deemed 
       approved) for original IDEs and amendments will be modified as follows:
         
       1.   The reference block will be modified to include not only the IDE 
            number and the name of the device but also the proposed indication 
            for use for the device as stated in the clinical protocol and the 
            HCFA Reimbursement Category: A (or B).          
       2.   HCFA will be added to the distribution list at the bottom of all 
            such letters.  The Document Mail Center (DMC) will be responsible 
            for mailing copies of these approval letters to HCFA.
       3.   An enclosure entitled, "Procedures to Request Re-evaluation of 
            Categorization Decisions" must be included in the approval letters 
            when a Category A determination is made.
         
       In order to create a written record of the basis for each 
       categorization decision, reviewers must complete the checklist provided 
       by the IDE staff (See Attachment B or document H-1 on the LAN).  By 
       using this checklist, the criterion which served as the basis for the 
       categorization decision of the investigational device will be included 
       in the IDE file as the checklist must be attached to the last page of 
       the review memo.  The categorization determination (category and reason 
       code) must also be recorded on the tracking sheets for all original 
       IDEs and amendments which are approved.  (If this information is not 
       included on the tracking sheet, the DMC will not be able to log the IDE 
       out of the tracking system.)  The DMC will be responsible for entering 
       this information into the IDE database when the IDE is logged out of 
       the tracking system.   
         
       The Office of Systems and Management has modified the IDE database to 
       capture the reimbursement category and reason code assigned to each 
       approved IDE.  Such modifications will permit both searching of the IDE 
       database and the generation of reports based on this criteria.  
         
       C.  Changes in IDE Status
         
       In the event that the approval of an IDE application is withdrawn, it 
       is imperative that HCFA be apprised of this fact as soon as possible.  
       Therefore, if after consultation with the IDE staff, the decision is 
       made to withdraw approval of the IDE application, the reviewing 
       division will be responsible for FAXing a copy of the final order which 
       withdraws approval of the IDE to HCFA at the same time that the  
       sponsor is notified of the withdrawal of approval.  (See IDE 
       boilerplate letter G-30A for the name of the HCFA contact person and 
       FAX number to which this information should be forwarded.)  HCFA should 
       not be notified of proposed withdrawal letters as these may not lead to 
       the final order.
         
       D.  Confidentiality of Categorization Determination
         
       As provided for under 21 CFR 812.38(a), all information pertaining to 
       an IDE, regardless of its status, is confidential.  This includes the 
       categorization determination. Thus, except for the information which 
       DSMA will post on its electronic docket, information regarding the 
       reimbursement categorization decision should only be released to the 
       sponsor of the IDE and to HCFA.  Therefore, the divisions should refer 
       inquiries (particularly those from physicians, patients, and insurance 
       carriers) pertaining to the HCFA reimbursement policy to Sharon Hippler 
       at:  HCFA, 7500 Security Boulevard, C4-04-05, Baltimore, MD  21244 or 
       (410) 786-4633.  
         
       E.  Sponsor Inquiries and Requests for Re-evaluation of Categorization 
           Decisions
         
       The division may discuss the basis for the reimbursement categorization 
       with the study sponsor.  A request for re-evaluation of the 
       reimbursement determination must be submitted in writing to FDA as an 
       IDE supplement.  Upon receipt of this request, the reviewing division 
       will reconsider the original decision and issue a letter setting forth 
       the basis of its final decision.  The appropriate boilerplate letter 
       (H-2 on the LAN) should be used when responding to such requests, and 
       IDE Staff concurrence must be obtained before the letter is issued.  
       After this point, the sponsor must refer any subsequent inquiries 
       regarding the categorization decision to HCFA as FDA's determination 
       may be only one of several factors considered when the reimbursement 
       decision is made and HCFA is the final arbiter of all reimbursement 
       decisions.
         
       F.  Updating of the Categorization Decisions
         
       If the circumstances which led to the original categorization 
       determination change (e.g., a PMA is approved for a device similar to 
       one under investigation), the reviewing division will be responsible 
       for reconsidering the categorization designation for all IDEs which may 
       have been affected by this change.  Any resulting modifications must be 
       immediately reported to the IDE Staff.  The IDE Staff will be 
       responsible for reporting these changes in the categorization 
       designation to both HCFA and the sponsor of the IDE (See boilerplate H-
       3 on the LAN). 
         
       Effective Date
         
       This memorandum is effective immediately.
         
         
         
         
         
                                     Philip J. Phillips
  

IDE Memorandum - #D95-2
                                                     Attachment A - Page 1 
           
          
                              Interagency Agreement                    
          
        Between the Health Care Financing Administration (HCFA) and the 
        Food and Drug Administration (FDA) regarding Medicare coverage of 
        certain investigational medical devices.
          
        I.   Purpose
          
             To establish a process by which FDA will assist HCFA to place 
             IDE devices into categories based on the level of risk the 
             device presents to patients.  This categorization will be 
             used by HCFA as part of its determination of which devices 
             meet the requirements for Medicare coverage under section 
             1862(a)(1)(A) of the Social Security Act (the, "reasonable 
             and necessary" clause).  To be covered under Medicare, the 
             device must be reasonable and necessary for the diagnosis or 
             treatment of an illness or injury, or to improve the 
             functioning of a malformed body member.
          
        II.  Authority
          
             The legal authority to enter into this Agreement is provided 
             in sections 1874 and 1862(a)(1)(A) of the Social Security Act 
             and sections 520(g) and 701(a) of the Federal Food, Drug and 
             Cosmetic Act.
                    
        III. Background
          
             In his National Performance Review, Vice President Gore 
             directed the health agencies of the Department of Health and 
             Human Services (HHS) to review their policies and processes 
             to determine which requirements could be reduced or 
             eliminated without lowering health and safety standards.  In 
             accordance with this directive, FDA reviewed its current
             regulatory approval processes and HCFA reviewed its Medicare 
             coverage policies for medical devices that have not received 
             full FDA approval.
 The Medicare program has historically interpreted the 
             statutory terms "reasonable and necessary" to mean that a 
             service or medical device must be safe and effective, 
             medically necessary and appropriate, and not experimental in 
             order to qualify for reimbursement.  For Medicare coverage 
             purposes, the term experimental has been used synonymously 
             with the term investigational.  Therefore, an approved 
             Investigational Device Exemption (IDE) application served as 
             an indication that the device was not "reasonable and 
             necessary" within the meaning of the Medicare program.  Under 
             this policy, Medicare coverage was denied for devices that 
             require, but have yet to receive, 510(k) clearance and those 
             that have received an IDE but have not received PreMarket 
             Approval (PMA).
          
             There is increasing recognition that there are devices which 
             are refinements of existing technologies or replications of 
             existing technologies by other manufacturers.  Many of these 
             devices are placed within the IDE category as a means of 
             gathering the scientific information necessary for FDA to 
             establish the safety and effectiveness of the particular 
             device, even though there is scientific evidence that the 
             type of device can be safe and effective.  Arguably, these  
             devices could be viewed as "reasonable and necessary" by 
             Medicare and recognized for payment if it were possible to 
             identify them in the FDA's process.
          
             Accordingly, FDA and HCFA are developing a revised policy to 
             meet the needs of Medicare beneficiaries.  The purpose of 
             this effort is to determine if it is feasible to expand.  
             Medicare coverage to include certain medical devices that 
             have not yet received FDA marketing approval/clearance 
             without compromising the safety of medical care provided to 
             Medicare beneficiaries.  The intent is to devise ways to:
          
             ·    assure Medicare beneficiaries greater access to advances 
                  in proven medical technology;
          
             ·    encourage clinical researchers to conduct high quality 
                  studies; and,
          
             ·    clarify Medicare coverage of reasonable and necessary 
                  medical services during clinical trials for 
                  investigational devices.
          
        
        IV.  Scope of Work and Responsibilities
          
             The Health Care Financing Administration, in conjunction with 
             the Food and Drug Administration, will develop a process to 
             differentiate between novel, first-of-a-kind medical devices 
             and newer generations of proven technologies.  New Medicare 
             policies will be established in accordance with the 
             requirements for Federal rule-making under section 553 of the 
             Administrative Procedure Act.
          
             This Interagency Agreement (IA) supports this process under 
             which HCFA will establish a stratified policy for Medicare 
             coverage of certain IDE devices under FDA review.  For 
             purposes of assisting HCFA in determining Medicare coverage, 
             the FDA will place all IDEs it approves in one of two 
             categories:
          
             ·    Category A - Experimental- innovative devices believed 
                  to be in class III for which "absolute risk" of the 
                  device type has not been established (i.e., initial 
                  questions of safety and effectiveness have not been 
                  resolved).  That is, FDA is unsure whether the device 
                  type can be safe and effective.
          
             ·    Category B - Non-experimental/Investigational - device 
                  types believed to be in classes I or II or device types 
                  believed to be in class III where the incremental risk 
                  is the primary risk in question (i.e., 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 FDA approval 
                  for that device type.1
          
             In order to properly categorize device investigations, HCFA 
             and FDA have agreed to employ criteria outlined in the 
             Attachment.  As experience is gained in making 
             categorizations, the criteria may be updated.
          
             For purposes of determining Medicare coverage, medical 
             devices classified under this system as "Category B: Non-
             experimental/Investigational," could be viewed as "reasonable 
             and necessary" if they also meet all other Medicare coverage 
             requirements.  In some cases, HCFA may also wish to conduct a 
             separate assessment of the device to determine medical 
             necessity and appropriateness specifically with respect to 
             Medicare beneficiaries.
          
             In support of this basic agreement HCFA and FDA agree to the 
             following:
          
             ·    FDA will assign each FDA-approved IDE to one of the two 
                  categories listed in the Attachment and notify HCFA of 
                  its categorization no less than each calendar quarter, 
                  either by electronic means or written communication.
          
             ·    Medicare coverage of devices under "investigation" is 
                  predicated, in part, upon their status with FDA.  In
                  the event a sponsor loses its category B categorization 
                  or violates relevant IDE requirements necessitating 
                  FDA's withdrawal of approval of the IDE, FDA will 
                  immediately notify HCFA in order that HCFA may 
                  reevaluate the coverage status of the device under 
                  Medicare.  HCFA will establish specific procedures for 
                  the withdrawal of Medicare coverage.  These procedures 
                  will be described in Medicare regulations.
          
             ·    FDA-approved IDE study protocols for each clinical study 
                  will require that devices be available in a 
                  circumscribed number of sites for an approved number of 
                  patients.  HCFA will provide Medicare coverage and 
                  payments in accordance with these limitations and other" 
                  protocol requirements (i.e., services provided by 
                  certain health care practitioners).
          
             ·    FDA will assign each IDE an identification code or 
                  number which will enable HCFA to establish special 
                  claims processing procedures for Medicare claims 
                  associated with the clinical trial.  FDA will complete 
                  this process for existing IDEs by November 1, 1995.
          
             ·    FDA will require that the sponsor/manufacturer and 
                  clinical-investigators adhere to,pertinent regulations, 
                  including obtaining informed consent for all patients 
                  participating in the clinical trial.
          
             ·    FDA will establish a process for the reconsideration of 
                  the categorization of IDE devices.  As part of this 
                  process, FDA will analyze all information submitted by a 
                  party in support of a request for reconsideration.  HCFA 
                  will establish-a process to review requests for 
                  reconsideration that are denied by FDA.  FDA will 
                  provide necessary technical and expert support relating 
                  to FDA's categorization of devices to HCFA during the 
                  review process.  FDA will provide information to HCFA to 
                  substantiate its decision on the categorization of each 
                  medical device under review.
          
             ·    Reimbursement under the Medicare program for a device 
                  under an approved IDE will be limited to what Medicare 
                  would have paid for a comparable approved device.

        _______________________
             Note: Under the Food, Drug, and Cosmetic Act, devices are 
        categorized into three classes.  Class I devices are the least 
        regulated devices.  These are devices that FDA has determined need 
        to be subject only to general controls, such as good manufacturing 
        practice regulations.  Class II devices are those which, in 
        addition to general controls, require special controls, such as 
        performance standards or post-market surveillance, to assure 
        safety and effectiveness.  Class III devices are - those which 
        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 Pre-Market Approval 
        (PMA).
    
        V.   Period of Agreement
          
             This agreement takes effect upon the signatures of the two 
             parties.  The policy will be effective when final regulations 
             are published in the Federal Register, expected to be on or 
             about November 1, 1995.  The agreement will continue in 
             effect for an indefinite period.
          
          
        VI.  Modification/Cancellation Provisions
          
             This Interagency Agreement (IA) may be modified at any time 
             by mutual agreement of the patties.  It may be canceled if 
             both parties so agree in connection with a review, or if a 
             Federal statute is enacted that materially affects the IA.  
             In the event there is a cancellation of the IA, that 
             cancellation will not be effective for at least 6 months.
         
          
        VII. Confidentiality of IDE Information
   
             FDA will provide HCFA access to all information in the IDE 
             application for making Medicare coverage and payment 
             determinations, insuring protection against program fraud and 
             abuse, and claims processing.  All IDE applications will 
             remain on FDA premises.  However, relevant portions of these 
             applications may be duplicated by HCFA, as necessary, for 
             purposes of Medicare coverage determinations.
          
             To the extent that such information is in the possession and 
             control of HCFA, it is subject to the disclosure and 
             withholding rules established by Federal statutes and 
             regulations.  Applicable Federal statutes include, but are 
             not limited to, the Freedom of Information Act (5 U.S.C. 
             552), the Privacy Act (5 U.S.C. 552a), the Social Security 
             Act (42 U.S.C. 1306a), and the Trade Secrets Act (18 U.S.C 
             1905).  Under this agreement, FDA will have a role in 
             ensuring that its data release standards are met, either by 
             reviewing any materials and paperwork to be released by HCFA, 
             or through some other forms of oversight.  Moreover, HCFA has 
             no present intention of disclosing, or authorizing
             the disclosure of, individual/patient or proprietary 
             information.
          
          
      VIII.  Points of Contact
          
          
             HCFA:       Thomas Ault, Director
                         Bureau of Policy Development
          
          
             FDA:        D. Bruce Burlington, M.D.
                         Director, Center for Devices
                           and Radiological Health
          
          
        IX.  Signatures of Acceptance
          
          
          
        8/29/95                    __________/S/__________________________
        Date                       Bruce C. Vladeck, Administrator
                                   Health Care Financing Administration
          
          
          
          
        9/8/95                     __________/S/_______________________
        Date                       David A. Kessler, M.D. 
                                   Commissioner of Food and Drugs
                                   Food and Drug Administration
     

Attachment
          
                        CRITERIA FOR CATEGORIZATION OF
                            INVESTIGATIONAL DEVICES
           
          
          
        Category A:      Experimental
          
        1.   Class III devices of a type for which no marketing 
             application has been approved through the premarket approval 
             (PMA) process for any indication for use. (For preamendments 
             Class III devices, refer to the criteria under Category B); 
             or
          
        2.   Class III devices that would otherwise be in Category B but 
             have undergone significant modification for a new indication 
             or use.
        
        Category B:      Non-experimental/Investigational
          
        1.   Devices, regardless of the classification, under 
             investigation to establish substantial equivalence to a 
             predicate device, i.e., to establish substantial equivalence 
             to a previously/currently legally marketed device: or
          
        2.   Class III devices whose technological characteristics and 
             indications for use are comparable to a PMA-approved device; 
             or
          
        3.   Class III devices with technological advances compared to a 
             PMA approved device, i.e., a device with technological 
             changes that represent advances to a device that has already 
             received pre-market approval (generational changes); or
          
        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; or
          
        5.   Pre-amendments Class III devices that become the subject of 
             an IDE after FDA requires premarket approval, i.e., no PMA 
             was submitted or the PMA was denied; or
          
        6.   Non-significant risk device investigations for which FDA 
             required the submission of an IDE.
          
        Note:  Some investigational devices may exhibit unique 
        characteristics or raise safety concerns that make additional 
        consideration necessary.  For these devices, HCFA and FDA will 
        agree on the additional criteria to be used.  FDA will then use 
        this criteria to assign the device(s) to a category.  As 
        experience is gained in the categorization process, this 
        attachment may be modified.
     

IDE Memorandum - #D95-2 
                                                    Attachment B - Page 1
         
                             CRITERIA FOR CATEGORIZATION OF
                                 INVESTIGATIONAL DEVICES
         
             Category A:  Experimental  
     
    _______  1)   Class III devices of a type for which no marketing 
                  application has been approved through the premarket approval 
                  (PMA) process for any indication for use.   (For pre-
                  amendments Class III devices, refer to the criteria under 
                  Category B); or
     
    _______  2)   Class III devices that would otherwise be in Category B but 
                  have undergone significant modification for a new indication 
                  for use.
     
             Category B:  Non-experimental/Investigational
     
    _______  1)   Devices, regardless of the classification, under 
                  investigation to establish substantial equivalence to a 
                  predicate device, i.e., to establish substantial equivalence 
                  to a previously/currently legally marketed device; or  
     
    _______  2)   Class III devices whose technological characteristics and 
                  indications for use are comparable to a PMA-approved device; 
                  or 
     
    _______  3)   Class III devices with technological advances compared to a 
                  PMA-approved device, i.e., a device with technological 
                  changes that represent advances to a device that has already 
                  received pre-market approval (generational changes); or
     
    _______  4)   Class III devices that are comparable to a PMA-approved 
                  device which are under investigation for a new indication for 
                  use.  For purposes of studying the new indication, no 
                  significant modifications to the device were required; or
     
    _______  5)   Pre-amendments Class III devices that become the subject of 
                  an IDE after FDA requires premarket approval, i.e., no PMA 
                  was submitted or the PMA was denied; or
     
    _______  6)   Non-significant risk device investigations for which FDA 
                  required the submission of an IDE.   
     
     
     
     
     ________________________________________
     Branch Chief                  (date)
     
     
     
      For Category A determinations only: 
     
     
     ________________________________________
     IDE Staff concurrence         (date)

Below is a list of the HCFA Reimbursements Categorization Determinations 
for FDA-Approved IDE's:

G780049 B 2
G780054 B 2
G790001 B 2
G790011 B 6
G790012 B 2
G790016 B 1
G790018 B 2
G790022 B 2
G790023 B 2
G790030 B 2
G790033 B 1
G800001 B 2
G800002 B 2
G800004 B 2
G800007 B 1
G800017 B 5
G800020 B 1
G800022 B 2
G800024 B 2
G800035 B 3
G800046 B 1
G800049 B 2
G800055 B 2
G800074 B 2
G800075 B 1
G800077 B 2
G800083 B 4
G800124 B 2
G800129 B 3
G800138 B 2
G800143 B 4
G810003 B 2
G810022 B 2
G810028 B 2
G810065 B 2
G810067 B 4
G810068 B 2
G810076 B 2
G810080 B 1
G810081 B 1
G810083 B 2
G810086 B 1
G810089 B 2
G810102 B 1
G810109 B 2
G810113 B 1
G810115 B 3
G810122 B 2
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