To contribute to the topic, I feel that a comprehensive Design Control System preserves the established feedback loop by accurately documenting the product while allowing for improvement throughout the development phases. As previously said, the FDA examines the company's processes to ensure that they are followed and that they do not deviate from them. Possible results may come from incorrect recording of steps during the procedure. During the remediation of a product/product line, I can think of one instance when the procedure has to be completely foolproof. Although every step of the process should be error-free, remediation requires documentation, people, and strict attention to protocol if discoveries are to be avoided.
FDA examine elements including sterility, electromagnetic compatibility, human aspects, performance characteristics, risk, and compatibility with the intended use environment. Input-output parameters, design transfer, risk analysis, and DHF are all examined. If the device is an imaging-based device, they will examine the program for validity and evaluate its dangers. In addition, the FDA examines all of the protocols and appropriate manufacturing-related documents.
The FDA primarily controls the documentation. It checks whether the documents are complete, whether they are filled in completely, whether the revisions that occur during the project are recorded. it also reviews the content of the protocols and whether the protocols have been implemented. The FDA does not want the end user to be harmed. this is why many devices are approved while many are rejected. In short, the FDA's priority is safety.
It is important to note that design controls are just a singular subpart that are reviewed to ensure compliance with quality system regulations. Design controls provide a formalized approach to designing and developing a safe and effective medical device. The FDA evaluates a Design History File (DHF) to understand the design and development process for each and every medical device they are presented with as well as to ensure the end product meets user needs. A well put together DHF will be complete with dates and signatures of individuals who worked on and oversaw/approved each phase of the process (design and development planning, inputs, outputs, and no blank spaces, ambiguity, reviews, verification, validation, transfer, and changes) with clear requirements, methods, and test plans leading up to production and manufacturing while leaving no blank spaces, ambiguity, and or conflicting requirements.
The first step to meet FDA’s requirement is following the design control. FDA looks if the medical device is developed following the design control so that in case of risk, that can be mitigated at the beginning of the product development phase. The goal of the FDA is to ensure that the product is safe and effective for the patient. Therefore, with strict rules and FDA guidelines, it is expected that the device will be harmless and effective. The design control validates the production performance and effectiveness. And FDA also investigates the DHF to ensure the product’s safety, accuracy, and effectiveness.
I believe the main reason the FDA needs a design plan is for risk. They need and want to find out that no corners were cut and that this product will not hurt the consumer.
