FDA’s 510(k) Process Under Scrutiny

By Santhosh Nair

Santhosh PhotoIn September of 2009 the FDA commissioned an independent committee review of its 510(k) process, the most common method medical device manufacturers use to bring lower-risk products to market.  In their resultant report, the Institute of Medicine (IOM) recommended a complete overhaul.  Although the FDA has dismissed the recommendations, they are continuing to refine the 510(k) process. This has caused a polarization of the industry experts, those supporting the IOM view and those against it. Those who oppose the current 510(k) process point to the FAA guidelines for more rigor, others point to the FCC guidelines for speed and efficiency, and some advocate for a newer, simpler, better process for lowering the barriers to entry and increasing the number of devices that make it to market. Those who support the 510(k) processes, primarily incumbent medical manufacturers, cite that there is no public health crisis with medical device approval that warrants an overhaul.

In my opinion, we need to evolve the current approval process, but overhauling may not be the right answer, and could tilt the balance in the wrong direction by increasing costs and reducing access.

Here are my thoughts:  

A totally new and simplified process, which is more research-based, straight-forward, clear, risk-based and still expedites innovation, may not be realistic at this time. There are hundreds of thousands of existing safe and reliable medical devices that are improving the quality of life. Medical device manufacturers have invested billions of dollars in setting up their current processes, design controls and documentation to conform to the current regulatory guidelines and 510(k) process. Overhauling this means very costly non value-add investments in new processes, more opportunities for errors, delayed product launches and an overall increase in the cost of healthcare. On an already overburdened healthcare system, this could wreak havoc. Moreover, the suggested adoption of the FAA model of certification, while introducing more rigor, would exponentially increase the cost of approvals, thereby raising the barriers to innovation and impede R&D; the cost structure and the players in the medical industry are very different from those in the aerospace and defense industry.

As the current 510(k) process is getting revised, the FDA is seeking public views on 510(k) plans.  We need to actively contribute to such forums and come up with collective feedback and ideas that the agency can use. There is already inter-continental collaboration that is happening between FDA and other regulatory agencies in other nations, and I would be surprised if the various regulatory agencies in the US aren’t collaborating already.  Comparative Effectiveness Research and other research methodologies are being mandated for any claims that are being made. Medical device manufacturers take extra precautions to ensure that their products are safe and effective, and the liability costs are way too high to be callous about.

The FDA will most likely always battle the challenge of being understaffed and overburdened. That said, they are operating well within their constraints.  In fact, medical devices in the US have an excellent track record of safety that is comparable to any other nation, and other industries within the country.

The FDA cannot do it alone; they need support from everyone in the value-chain of a medical device. What will happen to the 510(k) process in the long term is anyone’s guess, but it is here to stay in the short term. Medical device manufacturers must continue to improve on compliance, process rigor and quality so that they can constantly improve their track record for safety. They must also demand the same from their partners and suppliers.  Note: the FDA has publicly opened up the topic for discussion and will implement suggestions.

At Wind River, we take a no-compromise approach to quality. We comply with the rules and regulations of the industry that we serve. Our technologies are compliant to FDA and IEC guidelines for suppliers, and we will continue to raise the bar on quality and compliance.