Is an FDA 510k Clearance Alone Enough?

Medical companies strive for FDA 510k market clearance, but is relying on this achievement alone a bit of a gamble? Some companies seem to be simply compiling and submitting all of the required information prior to an FDA 510k submission without actually implementing and documenting the necessary quality systems. Here is why that is the wrong approach to take and how it can result in irreversible consequences.


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What Is FDA 510k Clearance?

FDA 510k is a pre-market submission made to the Food and Drug Administration (FDA) agency with the objective of proving that a medical device is equally safe and effective as one that is legally marketed and not subject to pre-market approval. Manufacturers must notify the FDA of their intent to market a device at least 90 days in advance.

So what companies can help with FDA 510k issues?

Being awarded the FDA 510k label is a meaningful achievement for any medical device company, but the review process can be full of many challenges, from time pressure to additional costs. For this reason, some manufacturers look to companies to help with FDA 510k to ensure that they are equipped to deal with a potentially lengthy and time-consuming process as well as unexpected questions and queries. In addition, international manufacturers may receive assistance by an overseas entity for convenience. Some of the principle agencies that offer FDA 510k consulting facilities are Intertek and Omnicon; meanwhile, Maetrics offers training courses to help companies prepare for their submission.

The Impact of Poor Preparation

What some companies don’t realise is that Design Controls, Risk Management and Quality Management Systems are paramount for those seeking FDA 510k approval. By not following these clear guidelines set out by the governing agency, companies could really be gambling with the fate of their company. However, it can take a year or two for companies to realise their mistake; often the FDA 510k review process will encourage future regulatory compliance questions. Not only that, but many companies may rely on funding from external sources based on the FDA 510k submission clearing. If this becomes a company’s sole objective and they begin to let other major processes lag behind, they could find themselves in a compliance nightmare, with little or no funding, that they simply cannot back their way out of.