The U.S. Food and Drug Administration (FDA) is stepping up its efforts to identify FDA-cleared medical devices that have been subsequently modified and that no longer fall within the scope of their original clearance.
An article posted to the website of JDSupra, summarizes a recent FDA investigation of the facility of a California-based medical device manufacturer (Q’Apel Medical, Inc.), during which inspectors identified several concerns regarding a previously cleared medical device. The issues included design modifications and misbranding concerns, each of which required the company to obtain a new 510(k) notification to reflect these changes.
Under FDA regulations, manufacturers seeking to make changes to medical devices originally cleared under the 510(k) process must conduct a risk-based assessment to determine whether the proposed changes alter the device sufficiently to affect the safety or efficacy of the device or lead to a significant change in its intended use. If so, the manufacturer is required to make a new FDA 510(k) submission.
The JDSupra article on medical device modifications is available at https://www.jdsupra.com/legalnews/step-by-step-fda-cracks-down-on-9002503/.
The FDA’s warning letter issued to Q’Apel Medical summarizing its investigation is available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/qapel-medical-inc-699244-02052025.
