Depending upon the class of the device FDA regulations do vary. The rules also vary accordingly depending upon the risk of the device. Device prototype is the most important part where a basic structure is shown and the properties and importance of the device is estimated.Refining the prototype provides researchers with important information about the product’s potential use for people. The prototype process attempts to reduce risk of harm in people. When the device is under FDA review it has certain things to be taken under concern such as Humanitarian Device Exemption, Premarket Notification and Premarket Approval Application. In addition to all approval process and application of the device into the market, maintenance of the manufacturing and design is the most important thing. FDA officials conduct routine inspections of medical device manufacturing facilities across the United States. Manufacturers may be informed of inspections in advance, or the inspections may be unannounced. Inspections may be routine or caused by a particular problem. The purpose of these inspections is to make sure developers are following good manufacturing practices. FDA can shut down a manufacturing facility if standards are not met.
Basically what the FDA looks for when they do an audit is to ensure all the documentation is proper and all the protocols are being followed properly. The FDA will try to find anything to mark down. They are not doing to harm the company but only to improve it. The FDA wants to make sure there are no hazards and no shortcuts are being taken to get the product on the line. This is one of the main reasons FDA takes a while to approve products and also why many products are being recalled. They're main goal is to ensure the safety of the users so that is why the FDA looks for the design control system to be in tact and proper.
The FDA has very strict guidelines that have to be followed in order to have a device reach the market. These protocols are just standard for FDA. The device may also need to be classified in terms of a Class I, II, III device. The FDA wants to make sure that the device does not malfunction and it is used appropriately and with essentially no harm to others. 44% of voluntary recalls could have been prevented by adequate design controls, which is why the FDA stepped in to make specific requirements for certain products. The FDA will consider the human interaction and the potential of the device to cause any harm that can potentially be fatal to the individual. It also has to approve of the premarket approval application and continue to inspect the device to make sure no changes are made and they are performing to the utmost ability.
The ultimate goal of the FDA is to ensure that products are safe and effective. These are the two most crucial factors of a medical device. For design control systems, the FDA is making sure that every phase in the process is contributing to some way for the device to be both safe and effective. The FDA is also looking for a system that is easily reproduced for each device that the company is creating.
Requirements for Design Controls
1. Design planning
2. Design input and output
3. Design verification and validation
4. Design review
5. Design changes
6. Design transfer
7. Design history file
Design Control is in place so that all documents are in place and everything can be back traced is place of problem.
Reviews are in place to on every steps those are:- user needs, device input, device process, device output,Medical Device.
Verification are done at device input and device output.
Validation is done at medical device and user needs just to verify if the device is working as its intended to work and if it really fulfills the purpose which it was made for.
I think FDA wants to know if the medical device companies are following the Design Control procedure and have valid design control procedure. They need to make sure that this companies have valid protocols they are following, because the main purpose of this is to know that this devices won't harm anyone. They are as follows: planning, input and output, verficiation and validation, review, changes, transfer, and history file.
Indeed, it is important that medical system companies design and develop a medical device that is safe and efficacy for the consumers to use. FDA, IND and other regulatory organizations want to regulate the product and assure that the medical device is safe and efficacy before it is sent into the market. The significance of Design control is that it is the validation of the products for its safe use while meeting all the consumer needs and requirements. As many of you have already mentioned, the requirements of design control initiate with general information, then Designing and developing the plan, input, output, review, verification, validation, transfer, and controlling the design with making changes, and it ends with designing the history file. Most important is keeping the history file, it is vital to keep all design control evidence.
Design controls are important in order to have a reproducible process for medical devices. The nine parts of design controls are all important to maintain and keep a record of in the device history file because that is where the FDA and other auditors will go to first to look for compliance with regulations. They look for proper documentation and for possible risks or hazards that may arise from producing this medical device. Most of all, they are making sure your device is safe and is thoroughly controlled throughout its procedures and protocols.
I believe for a complete design control system, they will look at the correct signatures for the documentations and see if everything is timed properly. If an instrument is being used and has the same time for two different things, that can bring up questions about how everything is done and if all the documentations. They will also look at the meeting minutes and see how often design review meetings occurred to see if everything was done smoothly. If the minutes don’t have it then they will question whether it was actually done. They will come in to see how a procedure is done to make sure people are following the procedures and SOPs or are they taking shortcuts. They will review new SOPs and methods made to make sure they are valid. These are all important steps to make sure everything is risk free. They will definitely look into risk analysis and make sure there are no flaws.
Design controls are a way to prove that you have done everything according to the procedures outlined by the FDA. It ensures that everything is accounted for in terms of risk management and that it performs the way it is designed to. Not only does this help the manufacturer for any liability issues but it also allows for future modifications. The design control document should have clear diagrams (if applicable) and it should allow any person to understand how you came up with this device and the steps you took to make it.
FDA investigators will determine if a design is appropriate, or safe and effective by evaluating the design control process, make recommendations based on whether the manufacturer has the required checks and balances in place, and verify implementation of the design control guidelines . Organizations should be remain creative, meet schedule team action and documentation are highlighted in the design control flowchart because of the critical part they play in obtaining compliance to QSR. s, and stay compliant in order to have efficient Design control system. controls. Organizations shall establish and maintain the proper documentation to ensure the specified design requirements are met.When reviewing the design control requirements. Risk analysis is also an important part of design control for which FDA will look for. FDA reviewers will verify the safety and effectiveness of the device. It is therefore essential that any risks and hazards are mitigated to acceptable levels.
FDA will first see that the product does not provide any risks to the person, also make sure that the standards set by the FDA are followed by the manufacturer and have a look at the Design Control Document especially the DHF and also verify if the trails if required were performed as per standards and the results match as mentioned in the file.
There are various things that the FDA will be looking for in a Design Contol System. (1)Design and development planning. (2)Design input: It has information about the intended use and sure needs. (3)Design output: It tells if the output meets the input requirements, and the design satisfies the users' needs and their intended use areas. (4)Design review: Where the design is against to be evaluated against its requirements. (5)Design transfer: Production specifications of the design. (6)Design changes: Any modification to the design along the development process of the medical device or product. (7)Design history file: 21 CFR 820.30. compliance with the design.
Having these documents is one thing, making sure that these documents aren't falsified is another. I think, along with ensuring that these documents are present and complete, the FDA most likely also looks into how accurate these documents really are. If the final product is not clearly documented or if it does not match the documentation, then it may potentially not function as documented and thus may hold a high risk to users. The FDA most likely ensures that not only is this documentation present but that this documentation matches the device and thus ensures user safety. I don't mean to imply that falsifying such data and documentation is common; but humans are prone to mistakes and, even if unintentional, errors in documentation can still dramatically hurt users.
One of the most important thing to have deign controls is to reduce the products recall and to save more humans. It also to assure that devices meet user needs, intended uses, and specified requirements by giving more attention to design and development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design, controlling design changes, reviewing design results, transferring the design to production, and compiling a design history file.
