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 G88-1
April 22, 1988 Review of Laser Submissions Purpose At the present time, submissions for lasers are reviewed by many ODE divisions; sometimes they receive concurrent review in two or more divisions. This fragmented review and responsibility compounds the management of the review process and consistency of labeling, and increases the time of review for these products. It also creates confusion and interferes with communications with product sponsors. The purpose of this guidance memorandum is to consolidate and streamline the review of submissions for medical lasers and laser accessories and to establish uniformity of labeling while at the same time maintaining the high level of expert review we have applied in the past. Laser Submission Review 1. At present, DSRD will assume responsibility for laser and laser accessory 510(k)'d devices of DSRD, DANRD, DGGD, DOED, and DOD. Each division will inform DSRD of the name of its laser device contact person who will serve as the liaison with DSRD. 2. New 510(k)s will be the review responsibility of DSRD. Each division will provide to DSRD a list of intended uses (i.e., indication statements) for each type of laser and laser accessory that has been found equivalent via 510(k), as well as for those with approved PMA's to assist in making 510(k) decisions. Respective divisions will be consulted in the review, as DSRD deems appropriate. With respect to "not substantially equivalent" decisions, DSRD will obtain review and concurrence of the respective division involved (reflected in the sign-out of the submission's yellow sheet). 3. Each division will provide a list of current IDE's that are to obtain clinical data intended to be submitted in support of 510(k)'s. These ongoing IDEs will be transferred to DSRD. Future submissions concerning these IDE's,(e.g., supplement), will be reviewed by DSRD with consultation with the original divisions, as deemed appropriate by DSRD. 4. All new IDE's will be sent in parallel from DMC to DSRD and the other division(s) involved. Within 2 working days of division receipt, DSRD and the division(s) will meet to decide whether the laser device is likely to proceed to the market via the 510(k) track or PMA track. 5. All laser devices requiring a PMA, and their respective IDE's will continue to be reviewed by the divisions responsible for the medical specialty. DSRD will provide the technical review of these submissions for the responsible division. 6. A copy of SE, NSE and IDE letters will be forwarded to the consulting division by DSRD at the time they are issued. Effective Date: This guidance memorandum is effective immediately.