This past January, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) announced its plan of action for implementation of its 510(k) and science recommendations. Under section 510(k) of the Act, announced in August 2010, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin. While safety is at the core of this regulation, is it also limiting the possibilities for innovation and delivering products to market?
According to a study by PricewaterhouseCoopers, developing companies have made significant gains in the last five years in medical technology innovation, edging closer to the US who still has the lead.
The report states, “emerging-market countries such as China, India and Brazil, despite comparatively weak healthcare system infrastructure, are quickly taking the lead in developing lean, frugal and reverse innovation. This type of innovation simplifies devices and processes, retaining essential functions while applying newer technologies that are more mobile, customized to consumers’ needs and less costly. Such innovation will enable these nations to leapfrog developed countries in innovative healthcare delivery.”
Stricter regulations also hurt the smaller companies from bringing devices to market faster. The extra time and costs associated with the stricter guidelines prohibit smaller companies from competing with larger firms, that are also gleaning the support of investors seeking quicker return. Are we hurting ourselves or protecting ourselves with the regulations like 510(k)?
Recently, the FDA announced its plan of action for implementing 510(k) and is scaling back on some of the extensive recommendations the agency originally issued in August 2010. The Director of CDRH, Dr. Jeffrey Shuren, emphasized the agency’s concern with facilitating innovation to promote the public health, which it intends to achieve by increasing predictability and reducing uncertainty in the premarket review of Class II medical devices. Called “the New Paradigm” it presents device manufacturers with two new optional approaches for obtaining marketing clearance for devices subject to 510(k) requirements: the “Special 510(k): Device Modification” option, which utilizes certain aspects of the Quality System Regulation, and the “Abbreviated 510(k)” option, which relies on the use of guidance documents, special controls, and recognized standards to facilitate 510(k) review.
The FDA believes that the New 510(k) Paradigm will provide considerable flexibility for the medical device industry in demonstrating substantial equivalence in 510(k) submissions. Over the next several months, the FDA will continue to review and analyze the procedures and promise to improve the 510(k) process. The medical device industry needs to stay aware and assist the FDA with its requirements so we can, first of all, improve our processes and ensure patient safety, while not stifling innovation which can provide patient benefit and not delaying its time to market. The U.S. is a leader in medical device technology and while the FDA is a necessary component of our success, working with the agency to help improve its regulations will benefit the industry as a whole.