In the current regulatory environment, it is difficult for medical device manufacturers to work with little to no predictability and transparency in the review process. This isn't to say the premarket review process shouldn't be rigorous. There shouldn't be any shortcuts. The Medical Device Manufacturers Association (MDMA) is in full support of appropriate clinical data as required to ensure patient safety, but the real problem stems from this lack of predictability. If the process becomes more stringent, it should be because evidence has proven stricter guidelines will produce safer, more effective products.
It's important to point out that no medical product is 100-percent-risk-free. There is always a risk-benefit analysis with all medical products. Proponents of a stricter process want to eliminate all risk before a product is cleared or approved. But that means that millions of patients will end up waiting for a technology that could improve or even save their lives and some may not have that time to spare.
Companies should be required to demonstrate that their products have a reasonable assurance of safety and efficacy. At that point, it's up to the physicians and patients to evaluate their specific situation and determine an appropriate treatment.
While there haven't been any formal changes made to the premarket review process, companies have been experiencing, for nearly two years, huge obstacles in getting their products cleared for commercialization. Before any changes are implemented, it is critical that all parties and decision-makers communicate with each other so that everyone realizes exactly what is at stake. It is essential that data should be presented to show that not only is there a problem with the current process, but any changes will indeed address any existing deficiencies. In the end, patient care and innovation must be the driving force behind any decisions.
MDMA appreciates the openness of the FDA leadership and has had excellent interactions with its staff as they examine the 510(k) premarket review process. The association wants to make sure patients have timely access to safe and effective products, but if pressure on the FDA results in adding requirements that don't ultimately enhance scientific evidence or improve patient care, it will have lasting, detrimental effects.
Mark Leahey is the president and CEO of the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that advocates for entrepreneurial medical technology companies. He has led MDMA since 2002 and has overseen the growth of the association which now has more than 250 members. Leahey currently sits on the Medical Devices Committee for the Food and Drug Law Institute (FDLI) and the Editorial Advisory Board of Medical Product Outsourcing.
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