Rappahannock Eye Center

Failure to investigate adverse device effects;failure to install password clearance on computer

You failed to investigate the failure of the _____ when operating in MS Access. The system locks up at random and it is unknown whether the software which controls the _____ during _____ which operates off of MS Excel, could be similarly affected. Disruption of the _____ or an incorrect _____ pattern could result from such an occurrence. According to an Office of Device Evaluation (ODE) medical reviewer of _____ investiagational studies, it is not known if there is any irreparable damage to _____ when and if _____ are interrupted in the course of a prescribed _____ pattern. However, irregular _____ leave the patient with a refractive error that is uncorrectable by any means to date.

No security password is used on the computer for entering of data or when sending data to the study monitor over the internet. Subject medical records are, therefore, easily accessible. 21 CFR 812.100 states that an investigator is responsible for ensuring the rights and welfare of subjects, which includes security of their records.

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.