By Jennifer D. Newberger –Though we are certain it was not only our blog post on the draft Medical Device Reporting ("MDR") guidance that persuaded FDA not to adopt some of the positions it proposed in its Draft Guidance, Medical Device Reporting for Manufacturers (July 2013), we were pleased to see that some of the issues we considered to be most egregious in the draft are absent from the final guidance, issued on November 8, 2016.One such example pertains to the issue of duplicate reporting between contract manufacturers and specification developers. In the draft guidance, FDA stated,For devices manufactured under contract, both the firm that actually manufactured the device (“Firm A”) and the firm that initiated the specifications and distributed the device (“Firm B”) are considered a “manufacturer” based on the definition of that term in 21 CFR 803.3. Under 21 CFR 803.3, both the firm that manufactures the device and the firm that initiates the specifications for the device are manufacturers who are required to report.

Complaint Handling BasicsThe countdown for a manufacturer to report a complaint to the US Food, and Drug Administration (FDA) begins the day any employee has information of a device complaint which reasonably suggests an adverse event has occurred.Broadly speaking, according to 21 CFR 803.3(c), complaints may be attributed to a device malfunction, failure of the device to meet specifications, problems with device design, labeling errors, or device use errors. After receipt, each complaint must be investigated to determine if there is a relationship between the complaint and the device.