Have you recently lost confidence in your ability to predict the success of the regulatory strategy for your medical device? You are in good company. Everyone in the industry is facing the same uncertainty. On April 1, 2010, MassMEDIC, the Massachusetts Medical Device Industry Council, hosted a seminar on the 510(k) process during which the speakers (Sue Finneran, Haemonetics; Paul Kim, Foley Hoag LLP; Rosina Robinson, MDCI; and Terry Sullivan, Gyrus ACMI) and the audience shared their grief and strategies on how to address the uncertain FDA regulatory environment.

You may be asking, “Why now?” The rigor of the 510(k) process and the effectiveness of FDA oversight of the medical device industry have recently been called into question. The Center for Devices and Radiological Health (CDRH) has recently been criticized for failure to formally classify remaining pre-amendment (pre-1976 Medical Device Amendments) Class III devices. This delay results in some Class III devices legally entering the market via the 510(k) premarket notification process. It is important to understand that these devices represent mature technologies and are subject to the same quality system and medical device reporting requirements as other 510(k)-cleared devices.

Another factor contributing to the uncertain regulatory environment is that payment of the required Medical Device User Fees to FDA has created a perception of a conflict of interest. There have also been allegations of senior management coercion of scientific review staff to clear a new medical device when the device did not show sufficient evidence of safety and effectiveness. When those same staff reported this problem, there was alleged retaliation. Most recently, it was reported that FDA questioned the quality of the third party review program. The fact that some devices are reviewed by the Center for Biologics Evaluation and Research (CBER) increases the environment of uncertainty due to differences in review processes and expectations.

Since his appointment as CDRH Director, Jeffrey Shuren, MD, has consistently promised process improvement. The buzzwords at the public meetings held on February 9 and February 18 were transparency, predictability, and adaptability. Actions to implement this philosophy began with the creation of an internal task force on the 510(k) review process, increasing transparency with the addition of total product lifecycle information to the CDRH Website, and promotion of greater harmonization with international standards as a means of increasing predictability in the regulator process. In this environment of uncertainty, it is certain that other actions will follow.

While these actions are noteworthy, the industry needs to live and do business in the changing regulatory environment while such “construction” is underway. Strategies identified at the April 1, 2010 MassMEDIC meeting included returning to the basics, sharing ideas with colleagues, and staying current with the rapidly changing regulatory environment. The speakers explained that while there are alternatives to the traditional 510(k) premarket notification process in format (the Standard Technical Document, or STED) and review process (using an accredited third party reviewer), not all FDA reviewers are comfortable with the STED document, a single STED document does not address regulatory needs even for the member countries of the Global Harmonization Task Force, not all devices are eligible to be reviewed by all third party reviewers, and use of third party reviewers increases project costs. Staying current may also in fact mean frequent communication with competitors in your market space and with CDRH to define the requirements for all sponsors and then document those expectations in the form of an industry-sponsored/industry-developed guidance document.

So what now? Pliney the Elder said, “The only certainty is that nothing is certain.”

Rosina has over thirty years of experience in regulatory affairs and healthcare delivery. She has authored numerous regulatory submissions of all varieties from RFDs and 513(g)s to PMAs and HDEs representing a wide variety of medical specialties, with particular expertise in the regulation of cardiovascular, minimally invasive and general surgical devices. She guides clients through all types of premarket regulatory and clinical trial activities including face-to-face communications between clients and the appropriate FDA center, including CDRH and CBER.

Rosina is a member of the Regulatory Affairs Professionals Society and the Association of Operating Room Nurses. Rosina also served as an adjunct professor in the Northeastern University Master of Science in Regulatory Affairs program, from 2003 to 2007.

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