CAMLAW: Complementary and Alternative Medicine Law Blog

FDA Creates Medical Device Postmarket Transformation Initiative

The Center for Devices and Radiological Health within the federal Food and Drug Administration is taking steps to increase its ability to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products.

'In January, 2006 the Center convened a senior leadership team (the Postmarket Transformation Leadership Team-PTLT) which included external medical device experts. The team's charge was to:

"evaluate the recommendations in the CDRH document, "Ensuring the Safety of Marketed Medical Devices - Executive Synopsis and Recommendations," (January '06), collect additional data as necessary, supplement the recommendations, if needed, and propose a prioritized implementation plan for a transformed postmarket process".

The report recommendations elaborated the four areas designated for improvement in the previous postmarket reports. They are:

Create a Culture of Collaboration
The Center should transform its operations by adding a permanent matrix of cross-cutting product-related groups over the current functionally-based organizational structure to foster information sharing, collaboration and, ultimately, more effective public health promotion and protection. The cross-cutting matrix is designed to ensure that collaboration occurs not just in crisis situations, but also as a part of routine, day-to-day operations.

Develop World Class Data Systems
Data input, mining, analysis, and tracking systems should be strengthened, improved, or created as needed for postmarket issues. Improvements to the Center's critical medical device data and information systems including MAUDE and the MDR system are highlighted as well as pursuing additional enhancements to enhance the Center's analysis and tracking capabilities.

Enhance Risk/Benefit Communication Efforts
CDRH should be a trusted, publicly identifiable source for safety information about medical devices and radiation-emitting products. To that end, an analysis of the communication needs of CDRH stakeholders should be performed, and a process for the development and dissemination of risk-benefit information should be done in collaboration with clinical practitioners and professional communities.

Collaborate on Enforcement Strategies and Outcomes
Both the quantity and the quality of Center /ORA interactions should be transformed through increased collaboration among CDRH, the Office of Regulatory Affairs, and the Office of Chief Counsel. Postmarket data and information should be considered when prioritizing inspections and the inspection preparation process should include a review of recent postmarket data. CDRH should develop ways to leverage the audit results obtained by accredited third-party auditing bodies. Enforcement data systems should be updated, and employees trained to use them. All available enforcement tools should be used, including civil money penalties.

Immediate priority actions were identified by the PTLT. They are to:

Create a matrix of collaborative product groups to complement the largely functional organization of the Center

Develop metrics and methods for tracking the handling of postmarket issues

Pursue the development of unique identifiers (UDI) for medical devices

Propose mandatory electronic MDR reporting

Revise and update the MAUDE system, and expand the premarket data-warehousing project to include postmarket needs

Increase the quality and quantity of Center/ORA/OCC interactions

Develop and implement a risk-communication strategy

Design a pilot project to test the usefulness of quantitative decision-making methods for medical device regulation across the total product life cycle

Enhance utility of MedSun programs'

More information is available at the Center for Radiological Devices and Health.

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Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law, with a unique focus on alternative, complementary, and integrative medical therapies.

Michael H. Cohen is also President of the the Institute for Integrative and Energy Medicine, also known as the Institute for Health, Ethics, Law, Policy & Society. The Institute serves as a reliable forum for investigation and recommendations regarding the legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care.

The most recent book written by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary and alternative medicine and related fields is an interdisciplinary collection of essays entitled, Healing at the Borderland of Medicine and Religion. This is the fourth book in a series, begun with Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998).

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