How to Overcome FDA 510(k) Clearance Barriers?

A FDA 510k clearance or premarket submission demonstrates that the device which is marketed is safe and effective as predicate. The FDA 510k process is necessary to enter into the US market / or to sell your device in the US market. The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR), found in 21 CFR Part 820 of the Code of Federal Regulations. The FDA 510 k clearance process is the most common pre-market pathway for medical device companies.  There are certain reasons due to which the 510k process gets delayed or the FDA 510k gets rejected, termed as FDA 510k clearance Barriers.  

The barriers faced during the FDA 510(k) clearance process: 

You might have designed a useful and wonderful product to manufacture but the first important thing is to get approval for the product or get the Clearance from FDA to market it. FDA I.e, Food and Drug Administration has set strict rules for medical device companies to market their product in the US. To commercialize the product manufacturer can follow the two ways first is premarket notification and the other is FDA 510(k). Premarket approval is needed for clinical and laboratory studies. The other path to commercialize your product is 510(k).  

The majority of medical devices approved in the US are cleared through the 510(k)process.  As an FDA 510(k) clearance process consultant we have guided and created a 510(k) dossier for many of them, which helped them in getting 510(k) clearance easily. Getting FDA 510(k) clearance is easy only if you submit the correct documents and follow proper guidelines.  

Let’s check out some FDA 510(k) clearance barriers and solutions to overcome them. 

• Wrong selection of Predicate Device. 
• Device does not comply with specific requirement. 
• Non-Technical Error. 
• Errors in the review process. 

Read More -  FDA 510k clearance barriers

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