Recalls

So your company needs to bring a product back from the field due to an oversight or a defect.  Perhaps your company needs to retrofit a product in the field with a new modification.  Maybe one of your company’s products needs its labeling (e.g., package insert or operator’s manual) supplemented with a new instruction or warning.  Does this constitute a recall or fit under FDA’s definition of a correction or removal per 21 CFR Part 806?  Will this needed action require a Medical Device Vigilance Report or a Mandatory Problem Report according to the EU Medical Devices Directive or Health Canada’s Medical Device Regulations? Regulatory Insight, Inc. can help you to determine the correct action to be taken. 

Regulatory Insight can assist you with the following tasks related to your field action:

     ]     Development of a strategy to first and foremost assure that safety and efficacy are 
                   immediately addressed, yet undue overreaction and panic are avoided.

]     Notification to the applicable regulatory bodies of your intended actions via the appropriate reporting requirements.

]     Writing and implementation of a customer notification related to your field action.

]     Development of a database to track timely and complete implementation of your field action.

]     Assurance of the timely and cost-effective completion of your field action.

]     Identification and assistance to implement preventive actions to avoid future occurrences leading to similar field actions.

 
Please contact us to assist you with the identification, development and implementation of an appropriate strategy for your company’s current field action.