Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff

Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health , January 31, 2023
Language(s):
English
Format:
Text
Subject(s):
Government Regulation
Lasers
Medical Device Legislation
Weights and Measures
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
This guidance is intended for manufacturers of laser products and outlines the Food and Drug Administration’s (FDA’s or the Agency’s) approach regarding the applicability of FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) laser products. The topics that are addressed include: (1) The definition of an SLA laser product (2) Considerations for what is an SLA laser product (3) Examples of SLA and non-SLA laser products (4) SLA laser product class limits (5) Requesting a variance or exemption from SLA laser product class limits. In general, FDA guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages))
NLM Unique ID:
9918590888006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918590888006676