FDA classifies intraoperative orthopedic strain sensors for class II assignment
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The FDA has announced a final amendment to classify intraoperative orthopedic strain sensors into class II with special controls, which will allow for increased patient access to innovative implant strain devices, according to a release.
The new classification, which is effective on Dec. 2, 2021, and applicable on March 28, 2019, now places orthopedic strain sensors in the intraoperative setting into class II assignment. According to the release, intraoperative orthopedic strain sensors were previously assigned automatically to class III by the FDA.
Additionally, the FDA identified several risks and mitigation measures for intraoperative orthopedic strain sensors. The identified risks included the following:
- prolonged operative time due to device error or use error;
- electrical shock or device failure due to interference from other devices;
- infection; and
- adverse tissue reaction.
Mitigation measures outlined in the release included the following:
- usability testing, non-clinical performance testing, software verification (including validation and hazard analysis) and labeling;
- electromagnetic compatibility testing and electrical safety testing; and
- sterilization validation, reprocessing validation, shelf-life testing, labeling and biocompatibility evaluation.
The full list of special controls and supplementary information are available in the document.
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