FDA WARNING_LETTER - Signal Medical Corporation - August 11, 2014

On December 15, 2014, the FDA issued a Warning Letter to Signal Medical Corporation following an inspection from July 31 to August 11, 2014. The inspection revealed that the firm, a manufacturer of Class II MicroSeal Total Hip Acetabular Systems, was marketing adulterated and misbranded devices.

The MicroSeal Total Hip Acetabular System was deemed adulterated because it lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Specifically, the system included a "hood feature" integrated with a liner (MicroSeal "Anatomic" and "Stable" liners) not cleared in previous 510(k) submissions (K955271 and K971718). Additionally, new liner inner diameter sizes (32mm and (b)(4)mm) were offered beyond the cleared 22mm, 26mm, and 28mm.

The device was also misbranded because Signal Medical Corporation introduced major changes/modifications to the cleared 510(k) devices (K955271 and K971718) without notifying the FDA or submitting a new premarket notification (510(k)), as required by 21 U.S.C. § 360(k) and 21 CFR 807.81