For companies who are not prepared to submit a 510k regulatory clearance, then the procedure can be painful for you. We have compiled a list of tips after having so much experience in the field so that it can help others have painless FDA 510k submissions.
Clearance is required before you can start the legal marketing process of the medical device product for the risks involved that ranges from medium Class II risk, High-Class III risk and the devices that are yet unclassified. However, the products that are associated with a low level of risks does not require any regulatory submission.
Majority of class II devices are cleared using the notification process which is commonly called 510(k) after the Federal Food, Cosmetic and Drug act reference number. The developer of the device is needed to submit an application that contains appropriate information about the design of the product, testing evidence, validation evidence late in the development program and the FDA clears the device for sale based on information provided. Clearance is given by some professionals who are known as FDA 510K consultants.
Class III high-risk devices require Pre-Market approval, where FDA comes into the picture at a very early stage of the development procedure. It should also have an agreed protocol that has details of product development that includes data for clinical validation of the device. The application should also be maintained for class III devices and it must be re-reviewed even if a slight change is being done to the device. However, there are exceptions for Class I devices that require submission of 510(k) but not in such a manner which is done for other higher classes.
● Plan your pathway – Many companies file 510(k) with several claims that include cures flat feet, bad breath, various diagnoses, etc. The approach of FDA 510k process should be in such a way that contains restricted indications for use, giving instances that the device is safe at the level of effectiveness for a desired and limited indication for use claim. Another indication can be added for use claims when the companies file other 510(k) submission. The first 510(k) filed states that the device is completely safe to use and it can be used in the clinical processes. The other 510(k) filed can have details which say that the device has a diagnostic performance with sensitivity, predictive values etc.
● Follow standards that are already recognised – Standards are based on the intention to demonstrate that the device has great performance and is safe to use. It may also lay both conditions in its report. With the introduction of “App” in the market, clients are nowadays trying to submit devices based on the combined system of PCs as well as tablets that are compatible with Apps and FDA wants to know that the complete system introduced is safe and doesn’t cause harm by any chance. Therefore, it is recommended for a submission that is software only.
● Resources should be enough to plan strategically both for development and launch – Companies that face a lot of troubles in the submission procedure are the ones who need just the rubber stamp from the FDA. Many companies have a dedicated person, such as VP of regulatory, the person can work with the FDA much closely, and can understand strategic pathways with the help of which you can resolve device suitability. The FDA gives “Safety and Effectiveness” priority and they do not care that how new a business is and how long will it take to grab the market.
You should always remember the saying “By failing to prepare, you are preparing to fail”. FDA doesn’t intentionally bounce back applications for getting more information on the device introduced by the company, instead, they have their norms set that should be met. You can use a well-planned submission from previous years as an example that contains all the necessary information so that the reviewer can easily carry out the procedure. Every company can’t have a resource available for the procedure so it is always recommended to discuss your case with experienced regulatory or FDA 510k consultant. This can make your task easier and pleasant.