Expect to hear speeches and proclamations aplenty as the FDA celebrates its 100th anniversary this month. Many of those speeches will discuss the administration's future, including plans to update its procedures and collaborate more with industry. In a nutshell, the FDA is working on two initiatives designers and manufacturers should become familiar with: the Critical Path Initiative and the Postmarket Transformation Initiative.

Getting products to market faster

The FDA launched the Critical Path initiative (www.fda.gov/oc/initiatives/criticalpath) in March 2004 to identify and prioritize the most pressing medical product-development problems and the greatest opportunities for rapid improvement. It intends to do this by applying the best available science to create new tools such as biomarkers and simulation models. The initiative aims to modernize product development so new medical discoveries are brought to patients faster and at a lower cost. FDA Acting Commissioner Andrew von Eschenbach says, “I am committed to Critical Path because it makes it possible for FDA's regulatory processes to become science-led, as well as science-based. We will retain the rigor, discipline, and the precision of regulation, but will move faster.” A faster, more nimble FDA? Stranger things have happened.

This March the agency released an initial list of priority research projects. The Opportunities List outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are now developed into therapies. Government, industry, and academic experts estimate that, if accomplished, the new tests and tools developed under the Critical Path Initiative will modernize the approval process by 2010.

The Critical Path Opportunities report is organized into six broad topic areas: development of biomarkers (measurable characteristics in animals or humans that can help predict a product's performance), clinical trial designs, bioinformatics, manufacturing, public-health needs, and pediatrics. The first two areas — biomarker development and streamlining clinical trials and collaborative projects — are deemed most important and are already underway.

The list was developed from feedback to the agency's 2004 Critical Path Report. It diagnosed a slowdown in the development of innovative medical therapies, and proposed an FDA-sponsored long-term initiative to address the problem. Research projects in the Opportunities List, intended to deliver smarter tools to evaluate candidate medical products, were identified through many sources including public comment, inter-agency consultations, and FDA product reviewers who know first-hand the obstacles encountered by medical-product development.

Keeping watch after approval

The Center for Devices and Radiological Health (CDRH) is taking steps to increase its ability to identify, analyze, and act on postmarket information. To meet this goal they have developed the Postmarket Transformation Initiative (www.fda.gov/cdrh/postmarket/mdpi.html) to ensure the safety and effectiveness of medical devices after they reach the market.

CDRH's postmarket program has three key components: problem identification, problem assessment, and public health response.

Postmarket problem identification tools identify public health hazards and enhance the quantity and quality of information about potential device risks. Key sources for problem identification include mandatory reports from manufacturers under the Medical Device Reporting (MDR) system, reports from hospitals enrolled in the Center's targeted surveillance system (MedSun), and information from inspections of manufacturers carried out by FDA. Information is also gathered from recall notification reports, bio-research monitoring investigations carried out by FDA, user complaints and comments, international vigilance reports, manufacturers' reports of medical-device modifications, and results of studies carried out by manufacturers after their products are approved.

Postmarket problem assessment. Based on information derived from the above sources, a team makes a scientific evaluation of the potential risk associated with adverse events from a medical device in question. FDA staff members, consulting with outside experts, analyze the data and identify the nature, magnitude, and public health significance of the problem. Recommendations are then made for an appropriate action to protect the public.

Postmarket public-health response. After assessing a postmarket problem, the FDA informs the public, the medical-device industry, and health care professionals about the identified risks using what the FDA calls public-health-response tools. These are risk communications such as Urgent Alerts, Multimedia Outreach, publications and presentations, and what are called enforcement actions.

The CDRH came up with specific goals to make sure it touches all components of the initiative. For example:

• Make sure people within the CDRH are working together to solve postmarket problems. To do this they'll identify sources of postmarket data and better coordinate the exchange of information among themselves and manufacturers.

• Build and manage effective information and knowledge systems to smoothly move information throughout postmarket processes, from data collection and analysis to public health action.

• Take advantage of what the Center learns about a device's postmarket performance by cycling this information back into the premarket review process for new designs.

• Through recruitment, training, and career development, ensure that the postmarket program functions well into the future, and that it adapts to changes in medical technologies and information systems.

• Partner with public and private enterprises in the medical-device community to ensure that the CDRH is communicating with them on an ongoing basis.

• Communicate risk information clearly and persuasively to appropriate device-user audiences.

Your head start starts now

As part of a proactive plan to deal with the FDA's initiatives, Medical Device Consultants Inc. (www.mdci.com/pages/nwsltr_06_03.html) recommends tapping into the following sources.

• MedSun (www.medsun.net) is a network of health facilities trained to recognize and report problems in real time.

• International Vigilance Reports. The Global Harmonization Task Force has guidelines for sharing information on products outside the U.S. (www.ghtf.org/sg2/sg2-proposed.html)

• Listservs (e-mail based discussion forums) and online discussion groups are used by professionals and consumers to discuss product performance, hazards, and ethical issues. These groups are occasionally monitored by the FDA to identify and report problems.

• Other sources include databases from the Centers for Medicare and Medicaid Services, the National Institutes of Health, and the Consumer Product Safety Commission.