S.u.A. Martin GmbH & Co.

a. The reason for changes made to the CNC software programs was not documented nor signed off by a designated individual.

b. When the CNC software is changed, the previous versions are overwritten or lost, thus making traceability of the software’s evolution impossible.

4. Failure to conduct processing control operations in a manner designed to assure that the device conforms to applicable specifications, as required by 21 CFR 820.100(b)(2). For example, the software program number and CNC machine identification were not recorded in the appropriate spaces on the instrument records.

7. Failure of the device master record to include production process specifications including appropriate equipment specifications, production methods, production procedures, and production environment specifications, as required by 21 CFR 820.181(b) . For example, specification ranges for the X, Y, and Z dimensions in the CNC machine software for each instrument have not been defined in the device master record.

b. The software program number and CNC machine identification were not recorded in the appropriate spaces on the instrument records in the device history 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

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