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The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

 

Priority #1: Advance Regulatory Science and Innovation

Under its first priority, FDA wants to facilitate the development of new biomedical products and emerging technologies. The agency plans to become more engaged in what it calls “mission-critical” fields of applied research, including wireless healthcare devices, nanotechnology, medical imaging, robotics and combination products. To support this goal, FDA is identifying strategies to recruit and retain top-level scientists and work more collaboratively with industry as well as other government agencies and academic institutions.

Also in support of better regulatory science, FDA wants to standardize the enormous amounts of product data it receives from industry. Now that the agency is getting more clinical data and medical device reports (MDRs) electronically, FDA believes standardized data will make its product review, approval and surveillance processes more efficient. The agency’s ultimate goal is to create a common database of harmonized information that allows its staff to compare multiple studies and reports and query the database by specific topics. As the first step for meeting this goal, FDA is developing a clinical trials data repository.

Priority #2: Strengthen the Global Supply Chain

The agency’s second priority is particularly relevant to the device industry, in which the use of outsourced suppliers for key components and assemblies is widespread.

FDA admits that the growing challenges of globalization have far outstripped its resources for inspecting and monitoring product quality. As a result, the agency wants to shift more responsibility to industry, expecting device makers themselves to identify and control supplier risks. In addition, the agency says that it may develop new regulatory standards to encourage corporations to monitor these risks throughout the product’s entire life cycle.

Priority #3: Strengthen Compliance and Enforcement Activities

As part of its third cross-cutting priority, FDA is implementing a number of new programs designed to make its enforcement systems faster and more effective. One is establishing new deadlines for industry to respond to significant inspection findings. Another is a new process for prioritizing follow-up inspections after the agency has issued Warning Letters, classified major recalls or taken some other significant enforcement action.

FDA’s enforcement plans also include creating more vigorous alliances with global regulators and standard-setting bodies. In the next five years, FDA wants to use its network of FDA field offices, local, state and territorial regulatory authorities and foreign government officials to share more laboratory and enforcement data.

A big component of the agency’s new enforcement focus will be criminal prosecution. Used sparingly in previous administrations, FDA’s criminal enforcement program includes prison sentences, fines, restitution and forfeiture. FDA says these criminal sanctions will be highly publicized, with the intention of informing consumers and making an example of bad-acting individuals and corporations to deter future criminal behavior.

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