Ophthalmic Instruments Division

21 CFR 820.184 (d), requires the Device History Record (DHR) to contain or refer to the location of records that demonstrate that the device is manufactured in accordance with the Device Master Record (DMR). Our investigator noted that the wavelength spectrum printout at 200 mWatts (mW) of laser power was not kept nor filed in the device history record. According to the device performance specifications described in your PMA application _____ Your firm uses a spectrum analyzer with the laser power meter to plot the energy units versus the wavelengths. The spectrum analyzer software generates a specific spectral curve and calculates the specific wavelength value at the peak power. However, your firm was not keeping a record of these specific printouts for each DHR to provide proof of readings or to verify the accuracy of the readings.

Also. the procedure for the initial laser diode alignment mior to system installation does not call for recording nor does it identify _____. Three examples of the computer printouts provided during the inspection did not contain the identification of the test operator, acceptance status or identification of the wavelength spectrum. This again appears to show inadequate receiving acceptance activities and documentation as required by 21 CFR 820.80 (b).


About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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