Lilly 483 Response

Numerous software issue response

The software and computer observations that can be found in the text are listed below:

-Response to Observation No. 16 a
-Response to Observation No. 18 and 18a
-Observation No 23
-Response to Observation No. 23 and 23a
-Observation No. 45
-Observation No. 49
-Observation No. 55
-Response to Observation No. 55 and 55a
-Response to Observation No. 55b
-Observation No. 55d
-Response to Observation No. 55c and 55d
-Response to Observation No. 61e

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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