Kremer Laser Eye Center

On May 8, 1996, you submitted an _____ for studies of _____ using an _____ (_____ hereafter “_____”). By letter dated June 7, 1996, (the _____ letter), FDA approved your _____ Under the _____ you may perform _____ to treat _____ for 300 patients at one institution. FDA also requested in the _____ approval letter that, within 45 days, you respond to a list of deficiencies regarding your _____ including a request that you submit information regarding “aspects of your device hardware, firmware, and software which mitigate against device failure and ensure adequate calibration of its output.”

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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