Safety is of utmost concern to manufacturers and governing bodies worldwide.
However, because the process can be complicated, European Union has issued several laws and guidelines over the past several years to address issues that occur as a result of safety monitoring.
Examples of such laws include those that govern pharmacovigilance audits. Given these increased regulations, it is important for pharmaceutical executives to be familiar with the regulations that pertain to pharmacovigilance audits, understand the objectives of these audits, and develop strategic planning for these audits.
Many manufacturers may wonder what mechanism is most appropriate to receive marketing approval from the FDA.
Most Class I, II, or III device devices are approved through a premarket approval. A premarket notification (510k) is deemed legally an authorization to market a device, and is 'authorized for sale by FDA', not approved by the FDA.
Because approximately 80% of the devices currently marketed in the United States were authorized through a 510k, it is important for manufacturers to understand when and how to use this mechanism.
The Food and Drug Administration recently issued a guidance to clarify when a change to a device constitutes a recall, distinguish a recall from an enhancement, and clarify the reporting requirements under 21 Code of Federal Regulations Part 806.
The guidance serves to clarify the Food and Drug Administration’s thinking about what constitutes a recall and what constitutes an enhancement.
Per the guidance, a recall occurs when a manufacturer removes a device that it considers to be in violation of regulations. The firm identifies a defect, determines that a recall is necessary, and goes through the recall process to remove it from the market.