Regarding the "Letters of Accession", Gary is correct, they really serve no useful purpose to the NRTLs. It is merely an acknowledgement that the report was received. The letter that could have 'traction' is the subsequent 'review' letter. That letter in most cases would state: "Your product report date MM/DD/YY, accession number XXXXXXX, has been reviewed and no further information is required at this time. Thank you for your continued cooperation." While it is true that the CDRH does not officially 'approve' a product, it is my opinion the review letter conveys acceptance of the demonstration of the product's compliance to 21CFR 1040. I have successfully used these letters with a large NRTL in demonstrating compliance with the radiation clauses in the ITE specs. There was one instance where the NRTL asked to see the report that was supplied to the CDRH, but they didn't discredit it.
The CDRH claims that they are under no obligation to send the 'review' letters. They usually do it automatically, but sometimes it 'falls through the cracks ' because they are short-staffed. If you don't receive one in a couple of months after receiving the 'Letter of Accession', call them and ask for one, they'll give you one. My experience, GE Interlogix John A. Juhasz Fiber Options Div. Bohemia, NY -----Original Message----- From: Peters, Michael [mailto:mpet...@analogic.com] Sent: Wednesday, May 15, 2002 12:19 PM To: 'Gary McInturff'; EMC-PSTC (E-mail) Subject: RE: 2 questions. 1) HP software for 7400A analyzers, 2) FDA lette rs of Accession Gary, I cannot comment on question 2) We use the E7415A software with an E7402A EMC Analyzer. The software is useful for the following: 1) Save calibration data for multiple instruments. 2) Program your own limit lines and use the ones pre-installed 3) Multiple setups (antennas, cables, lisns etc.,) 4) When you select a setup and communicate with the analyzer, the limit lines and corrections are loaded into the analyzer. 5) Display multiple traces on the same graphs (log and lin scales). This can assist in determining ambient from emission. 6) Graphs and tables are easily imported to Excel and/or Word (WordPad). 7) Make QP, Peak and Average measurements from computer and compare to limits. Feature 5) is probably the selling point of the software. You can generate an ambient trace and then compare trace(s) of when the equipment is on to quickly determine whether a spike is an emission or not. The caution with this is if emissions fluctuate a great deal. There are ways around this when you become familiar with the software. The license is controlled with a hardware key on the parallel port of the computer. The software will only communicate with an analyzer on the IEEE 488 bus if the key is installed. The software maintains most of its functionality without the key, so you can have a dedicated analyzer PC and then work on the data on another. The only negative I can think of is that the connection is a little slow and sometimes the analyzer gets locked into remote mode. If you end up using the software, be careful with the MAX HOLD and View traces. The software imports the "1" trace. If this is on Max Hold or View and the analyzer span is less/greater than what you set in the software, the graph will repeat the display of the MAX or Viewed trace on the computer display. This will result in an erroneous graph. The data file sizes can be large (5 to 10 MB) if you perform multiple "scans". I definitely think you can speed up scans and get more use out of your EMC analyzer with the software. Michael Peters -----Original Message----- From: Gary McInturff [mailto:gary.mcintu...@worldwidepackets.com] Sent: Tuesday, May 14, 2002 6:26 PM To: EMC-PSTC (E-mail) Subject: 2 questions. 1) HP software for 7400A analyzers, 2) FDA letters of Accession 1) I believe someone out there commented on using the HP 74XX series analyzer for pre-compliance measurements. Do you also use the additional software that can be purchased? The unit I played with had no additional software, but I could make measurements against limits lines etc, and it factored in the transceiver gains/losses and then allowed me to export a summary sheet for any reports I wanted to generate. What functions and value does the additional software bring to the table.? 2) Does anybody out there get any traction from a "Letters of accession" that the FDA sends to a optics vendor after receiving a request for a model addition? This letter says nothing useful for NRTL's and always includes "This acknowledgement does not constitute approval or the document". The FEDS are disavowing any level of conformity assessment, and the NRTL's I use tell me they can't use it, even for an unrecognized componet, yet the vendors are insistent that I am the only unaccepting curmudgeon in the entire universe. Sorry if you've heard this before but I just can't believe it keeps happening, and that tells me that I should double check my facts. Thanks Gary ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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