FDA WARNING_LETTER - Electronic Development Labs, Inc - November 05, 2013

The FDA issued a Warning Letter to Electronic Development Labs, Inc. on October 1, 2014, following an inspection from October 29-31 and November 5, 2013. The inspection determined the firm manufactures the Nervo-Scope device, which is a medical device.

The firm's Nervo-Scope devices were found to be misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), due to failure or refusal to furnish required material or information under section 519 of the Act (21 U.S.C. § 360i) and 21 CFR Part 803 - Medical Device Reporting (MDR).

A significant violation identified was the failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. During the inspection, management informed the FDA investigator that the firm did not have an MDR procedure. The firm's November 20, 2013, response, which stated that MDR procedure development was added to an action item list, was deemed inadequate without a copy of the procedure for review. The FDA also noted the eMDR Final Rule, effective August 14, 2015, requiring electronic submission of reports.

The FDA requires prompt