Hi, Peter. Since a phototransistor is not an emitter, classification should be unnecessary. There must be something else involved or its classification is as part of a system that includes an emitter. I wonder if it's mislabeled.
The FDA does have requirements for quality control systems, which are typically required at the time a report is submitted to the FDA for review. Pretty loose, but the expectation is that your company does whatever is necessary to ensure the certified laser class is not exceeded, which can include receiving inspection activities. However, unless your company is the certifier of the product, your obligations are limited. Refer to 21CFR, §1002 at http://www.fda.gov/cdrh/comp/eprc.html and http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.cfm?alpha=l (scroll down to the section on lasers for scads of information) Regards, Peter L. Tarver, PE [email protected] > From: Peter Hays > Sent: Thursday, October 27, 2005 1:51 PM > > Hello group, > > We have a product that contains a small photo > transistor that is classified as “laser class > 1M”. My question is that is there any specific > procedure as far FDA is concerned that we need to > put in place in our receiving inspection > department? i.e. do we need to do follow any test > or record keeping? > > Thanks > Peter > _____________________________________________________________________________ Scanned by Sanmina-SCI eShield _____________________________________________________________________________ - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
