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U.S. Department of Health and Human Services

Medical Devices

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Review of Laser Submissions #G88-1 (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 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.