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U.S. Department of Health and Human Services

Medical Devices

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Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) (Text Only)

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.

General Program Memorandum #G90-2

                                    

Date:  Oct. 19, 1990                 

From:  Director, Office of Device Evaluation (HFZ-400)

Subject:  Consolidated Review of Submissions for Diagnostic Ultrasound 
            Equipment, Accessories, and Related Measurement Devices

To:  ODE Review Staff


Purpose.  The purpose of this guidance is to promoted uniformity 
and efficiency in the review of submissions for Diagnostic Ultrasound 
Equipment, Accessories, and Related Measurement Devices.  510(k) 
submissions for these devices may have been reviewed in different 
divisions depending upon the intended use of a specific device.  This 
guidance assures the consolidation of responsibility for review of 
510(k) submissions and their supporting IDEs for these devices 
within one division, while at the same time maintaining inter-
divisional consultations, as necessary, to assure the high level of 
expert review that has been applied in the past.  This memorandum 
clarifies the roles and responsibilities of the primary reviewing 
division and the consulting divisions and sets forth the procedures 
they will use for this review process.

Identification of Divisions and Devices.  The following 
divisions and devices are the subject of this memorandum:
      
      -  Consolidated Devices:  DIAGNOSTIC ULTRASOUND EQUIPMENT,
                                ACCESSORIES, AND RELATED
                                MEASUREMENT DEVICES

      -  Primary Division:      DIVISION OF OBSTETRICS/GYNOCOLOGY,
                                EAR, NOSE, THROAT, AND
                                DENTAL DEVICES

      -  Consulting Divisions:  ALL ODE DIVISIONS, EXCEPT THE
                                DIVISION OF CLINICAL LABORATORY
                                DEVICES

510(K)s and Supporting IDEs.  

      -  The Primary Division wil be responsible for the review of 
      510(k)s and supporting IDEs for the Consolidated Devices.

      -  The Consulting Division will provide to the Primary Division 
      the name of its contact person who will serve as the liaison 
      with the Primary Division concerning 510(k)s and IDEs for the 
      Consolidated Devices.
   
      -  The Consulting Divisions will provide to the Primary Division 
      a list of intended uses, i.e., indication statements, for all 
      Consolidated Devices and their accessories that are subject to 
      this memorandum and that have been found to be
      substantially equivalent via 510(k) decisions including a brief
      statement regarding currently required data to support these
      decisions.  In addition, the Consulting Divisions will also
      provide, when applicable, a list of Consolidated Devices that    
      have approved PMAs and relevant PMA information that will     
      assist in making 510(k) decisions.

      -  The Consulting Divisions will provide to the Primary Division
      a list of current IDEs that are approved for the purpose of    
      gathering clinical data in support of a 510(k) for the       
      Consolidated Devices.  These ongoing IDEs will be transferred to 
      the Primary Division.  Future submissions concerning these 
      IDEs, e.g., amendments, will be reviewed by the Primary   
      Division.  The Primary Division, in turn, will obtain feedback
      from the Consulting Divisions, if necessary.

      -  During the review of 510(k)s for the Consolidated Devices, 
      the Primary Division will seek input from the Consulting 
      Divisions whenever necessary, such as when a 510(k) contains 
      an indication statement that raises the possibility that a new 
      use may be intended.  After a new insicatiion statement has 
      been approved via the 510 process a few times, the Primary  
      Division will seek consultation only when deemed appropriate.

      -  When input is sought from a Consulting Division, all 
      necessary feedback will be provided to the Primary Division 
      within 30 days.  With respect to "not substantially equivalent" 
      decisions, the Primary Division will obtain the review and 
      concurrence of the Consulting Divisions, which will be reflected  
      in the yellow sign-off sheets.

PMAs and Supporting IDEs.

      -  As in the past, a PMA and its supporting IDE for a 
      Consolidated Device will be reviewed by the division
      responsible for the medical specialty for whose use the device 
      is intended.  This may be the Primary Division or a Consulting 
      Division, depending upon the specific device and its intended 
      use.  If the reviewing division for the PMA/IDE is a Consulting 
      Division, the Primary Division, when requested, will provide
      the technical review of these submissions for the reviewing 
      division.

New IDEs.

      -  The POS/DMC will send all new IDEs for Consolidated Devices 
      to both the Primary Division and the Consulting Divisions.
      Within two days of receipt of the IDE, the Primary Division and 
      the Consulting Divisions will meet to decide whether the device is 
      likely to proceed to market via a 510(k) or PMA.  The 
      Primary Division will be responsible only for 510(k) track IDEs.  
      The PMA track IDE will be reviewed by the division that will 
      review the PMA, as discussed above.

Other General Procedures.

      -  The Primary Division will send copies of all 510(k) and IDE 
      decision letters to the appropriate Consulting Division at the 
      time each is issued.

      -  The Primary Division will conduct monthly or bimonthly 
      meetings with the Consulting Divisions to provide an update on 
      the status of reviews and actions taken since the previous  
      meeting.

      -  Issues between the Primary Division and the Consulting   
      Divsions that are not resolved at the review level will be 
      documented and presented in a timely manner to the affected  
      division directors for resolution.  If any issue cannot be 
      resolved by the division directors, they will refer the matter to 
      the Office of the Director, Office of Device Evaluation.

Effective Date.  This guidance memorandum is effective immediately.

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