Case Study: FDA 483 on MDR Reporting

A U.S. distributor of ophthalmic devices received a 483 Inspectional Observation because they did not clearly document the rationale for deciding that an adverse event was not MDR reportable.  They needed to respond in 30 days and did not have the expertise needed.

An AlvaMed consultant created a more comprehensive MDR/Complaint Analysis procedure which included a form with detailed questions and decision points based on the FDA regulations for determining whether an adverse event is a reportable event.  The consultant then worked with the firm to document the prior incident using the new form.

Use of the form indicated that the prior incident was not reportable.  A copy of the procedure and completed form were sent to the FDA in response to the 483 which was then considered closed by the FDA.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control