Biomet Ltd.

3. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). This would also be a violation of the Quality System Regulation, 21 CFR 820.70(i). For example, no documentation of specific software changes, which were made to the _____ production engineers on Program File _____ was maintained and specific changes made were unknown. Your responses, dated March 26 and April 15, 1997, are adequate. Procedures were revised for modifying the _____ .

7. Failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. This would also be a violation of the Quality System egulation, 21 CFR 820.70(i). For example:.

We acknowledge that you have submitted to this office responses concerning our investigator’s observations noted on the form FDA 483. It appears that the responses are adequate where it addresses those observations relating to software changes, Device Master Record, failure investigation reports and complaints, software validation, employee awareness of responsibilities and defective devices, and documentation of air velocity and positive air pressure gradient monitoring.

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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