AMENDMENTS TO CDRH LASER STANDARD

TEPRSSC ‘99 Revisited. Presentation Summary. Discussion Summary

TPRSSC ‘99 Presentation Motivations History Proposed CDRH Amendments (FR 3/24/99) Status of IEC Options for CDRH

TEPRSSC ‘99 Panel Discussion Motion approved: –Wait for IEC votes –Proceed with all due haste Other discussion: –CDRH taking the lead –Do not include LEDs –Reduce CDRH/IEC gap NOT Discussed: –Vertical standard for toy/novelty lasers

STATUS OF THE IEC AMENDMENTS  CDV approved 15:1 9/30/99  TC76 Plenary voted (11/12/99) to distribute FDIS for vote in 04/00  FDIS delivered to IEC CO 3/1/00  IEC plans to distribute FDIS in June with voting to close in August  If approved, the amended IEC standard may be published in October, 2000

TEPRSSC ‘00 Handout (Briefing Package) Draft revised proposed amendments to the CDRH Standard Revisions based on presumption of approval of the IEC FDIS Revisions are still an incomplete draft

WHY REPROPOSE? Significant changes since 1999 proposal –1999 based on 1995 IEC Scheme –1999 IEC CDV for 2000 Amendment Hew Classification scheme New measurement requirements New AELs w/short pulse limits & photochemical vs thermal limits

HIGHLIGHTS OF REVISIONS Class designations 1, 1M, 2, 2M, 3R, 3B, 4 Update emission limits –Short emission durations s. –Photochemical vs. thermal limits Human access criteria

HIGHLIGHTS OF REVISIONS (Cont.) Classification measurements Service information Class 1 Limit for novelty/toy laser products Clarify military exemption requirement

PRESENT TASKS  Complete draft revised amendments for CDRH standard.  Rework IEC FDIS into CDRH format  Prepare preamble Analysis of comments from 3/24/99 FR notice.

FUTURE TASKS  Agency clearances  OCC  OMB  FDA  Impact analyses  Rollout  CDRH Staff training  Revision of guidance documents, report guides  Field training  Industry education

TEPRSSC INPUTS Agreement w/reproposal Technical comments What if IEC FDIS not approved –Modify reproposal –Continue w/reproposal