Medical Equipment Designs Diathermy devices

Medical Equipment Designs 9-March-99 Diathermy devices

Since 1990, you also modified the design of the Meditherm
by introducing software to control the device. Major changes in the intended use of
the Meditherm and design changes which could significantly affect safety or
effectiveness, such as the introduction of software, require a new premarket
notification (510(k)) submission (Title 21, CFR, Part 807, Section 81(a)(3)).
Because you do not have marketing clearance from FDA for your current
Meditherm device, marketing your product is a violation of the law.

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.

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