Devices and Radiological Products

In the United States, medical device law is being dramatically reconfigured in response to Food and Drug Administration Modernization Act (FDAMA) mandates and increasing budget and resource constraints within the Center for Devices and Radiological Health (CDRH). These changes affect small startup companies and large multinationals alike. Now more than ever, companies need sophisticated and experienced assistance to navigate through CDRH and resolve CDRH-related issues.

Within this new and complicated regulatory environment, our strategic assistance at the premarket stage focuses first and foremost on avoiding costs and saving time. We assist with Section 510(k) premarket notification, Investigational Device Exemption (IDE), and Premarket Approval Applications, panel reviews, scientific disputes and appeals, resolution of jurisdictional uncertainties, and device modification analyses.

At the post-market stage, we provide the full range of services to ensure that product marketing strategies are optimized and that compliance and other liability exposures are controlled to the extent possible. To maximize market potential, we provide creative promotional, reimbursement and marketing/distribution strategies. We support day-to-day compliance activities by offering technical advice on such issues as medical device reporting, Good Manufacturing Practices, and recall and field corrections. As part of our regulatory counseling, we anticipate, and seek to contain, product liability exposure.

When enforcement concerns have arisen, we have assisted in some of the largest and most complex government investigations and settlements of the last decade. As the FDA, Department of Justice (DOJ), Health Care Financing Administration (HCFA), and Office of Inspector General (OIG) of the Department of Health and Human Services continue to take an aggressive enforcement stance, we regularly assist clients in responding to civil and criminal enforcement and compliance actions, including FDA Form 483 and Warning Letter responses, Import Alerts, consent decree issues, FDA’s integrity policy, OIG suspension and exclusion authority, and debarment penalties from government contracting agencies. Our white-collar criminal litigators regularly team with us on investigations, negotiations and litigation and other defense strategies.