Activity

  • dipanpatel replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    The cost of regulation I believe is just. Companies pay millions of dollars in applications and fees in the process of releasing their product. These expenses pay for testing and regulations processed done on the product,and also to the subscription of forms and services. As the FDA’s job is to make sure the processes are done properly and safe for the public which involves a reasonable fee which need to pay. I understand the concern that start up companies might not have the resources needed for the monetary aspect of the regulation processes, therefore the FDA should take it case by case depending on the size of the company. Each company hires employees that take care of regulations associated with ISO, FDA, USP to make sure the it done properly on the side of the company. This job is a paid one and money is a good way to make sure corners are not cut, therefore the cost of regulations processes are just.