Bioresearch TMJ diagnosois software

Bioresearch 3/31/98 TMJ diagnosois software

Your firm failed to obtain a new 510(k) or pre-market approval after making significant changes to the BioPAK System. Analysis software, i.e., “The Interpreter,” was added to the system to aid in the diagnosis of temporomandibular joint disorders. In addition, your firm is promoting an indication for use (“implants”) that is not covered under your existing 51O(k)’s.

The SonoPAK device received 510(k) clearance on May 15, 1991 (K905657/A). A copy of the 51O(k) letter is enclosed. This letter informed Bio-Research that “…a new 51O(k) is necessary if you intend to make any change to the labeling, promotional material, or indication statement for the SonoPAK/QS, SonoPAK.” The letter also states that a new 510(k) is necessary for “…any change to your device’s system requirements specification including software and firmware.”

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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