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Lasermet's Latest News > FDA Reports – annual submission obligation for laser manufacturers

FDA Reports – annual submission obligation for laser manufacturers


25/07/2016 - Lasermet's Annual Report Service fulfils all of the annual reporting requirements specified by the FDA.


FDA Reports – annual submission obligation for laser manufacturers

Many of our customers have asked us about FDA annual reports because they were either not aware that they were required, or they were unsure about exactly what information was needed.
As a result, Lasermet now provide an Annual Report Service which fulfils all of the annual reporting requirements specified by the FDA. i.e. where all manufacturers of laser products, components and systems are obliged to submit an annual report.
This year’s report cover the period from 1st July 2015 to the 30th June 2016 and must be submitted by the fast approaching deadline. All details of active products and recently discontinued products must be included. This enables your accession number to be kept live and should be submitted for five years after the product has been discontinued.
If an annual report is not submitted for a number of years, the accession number can be removed by the FDA. Please note that they will not normally contact you to make you aware of this.
If you have not submitted a report for five years or more, Lasermet can submit an up to date report to gain a new accession number.
The collation, researching and answering of the numerous questions and the submission of the FDA report in the correct format at the appropriate time is the service we can provide for £265 per report.
If you would like Lasermet to take care of this on your behalf please call 01202 770740 or email office@lasermet.com with a heading Annual Report Service.


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