Paradigm Medical Industries – Part 11

Failure to maintain accurate, complete, and current records of device accountability [21 CFR 812.140(b)(2)]. There is no documentation of the number of_____ and _____ manufactured and distributed, the number of copies of the controlling software made, or the disposition of each copy of the software. There are no records showing to which sites the device was shipped or whether the required software was supplied. There is no documentation to show when sites were given keys to turn on and use the _____ or when keys were retrieved from sites where the study was reportedly closed. There is also no documentation to show when the modified _____ was installed at each site and whether or not this change in any way affected the investigational device.

Electronic records, the subject of SOP-xxx, Electronic Database Maintenance, are subject to 21 CFR Part 11 – Electronic Records; Electronic Signatures, as well as to the recordkeeping regulations found in 21 CFR 812.140.

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:

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