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| HHS/FDA | RIN: 0910-AF87 | Publication ID: Spring 2008 |
| Title: Laser Products; Amendment to Performance Standard | |
| Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA’s performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard (to achieve harmonization and reflect current science), include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 1010; 21 CFR 1040 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 21 USC 360hh-ss | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone:240 276-2347 Fax:240 276-2352 Email: myrna.hanna@fda.hhs.gov |
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