Sonotech Inc.

Recipient: Sonotech Inc.
Product:Ultrabio Sterile ultrasound coupling gel
Date:8/8/06

Failure to validate processes that cannot be fully verified by subsequent inspection and test; failure to establish and maintain procedures for finished device acceptance; failure to maintain a device master record that referred to the location of the packaging and labeling specifications; failure to conduct quality audits by individuals who do not have the responsibility for the matters being audited; failure to follow internal quality audit procedures; failure to establish and maintain procedures for validating the device that include software validation and risk analysis; failure to maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements; failure to establish procedures to control all documents; and failure to maintain your procedures to control product that does not conform to specified requirements.

Your firm failed to establish and maintain procedures for validating the device that include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). The risk analysis for the Ultrabio does not meet the requirements of procedure “Design Input Checklist & Risk Management,” document No. PD-03, Revision 04. The risk analysis fails to include the analysis of the probability of occurrence of an identified hazard, the decision on whether the estimated risks are so low that risk reduction is not needed, and is not signed by the person who conducted the risk analysis.

FDA District:Seattle District Office

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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