May 28, 2015 — Signal Medical Corp. has been issued a warning letter after the FDA found that it made “major changes” to the MicroSeal hip implants without seeking approval or testing the new product for safety.
According to the warning letter, the FDA said the MicroSeal device was sold with two hood liners that were not included in the 510(k) approval application.
Signal also sold additional sizes of the MicroSeal Acetabular Liner after the initial 510(k) application was approved.
The problem was discovered during an inspection in July and August 2014. Investigators discovered that Signal made significant design changes, added new sizes, and modified the design of the shell and liner without clearing those changes with the FDA.
The warning letter was issued on December 15 and recently released publicly. The agency said Signal’s response in August was insufficient:
“During the close of the inspection, the investigators discussed the observed device design changes to the MicroSeal total hip acetabular system, a 510(k)-cleared device. The 510(k) changes as described above were not covered in your response letter.”
The 510(k) application process has been criticized because it allows manufacturers to sell new devices so long as they are “substantially equivalent” to another device on the market. Unfortunately, small modifications add up over time. Even devices with only slight differences can introduce new safety hazards.
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