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. \s\