The FDA today revealed a draft version of its 4-year plan, laying out strategic priorities and goals for keeping patients and consumers safe while addressing industry concerns.

The agency highlighted 5 primary areas of concern: regulatory science, globalization, safety & quality, smart regulation and stewardship. Regulators plan to focus on these areas over the next 4 years in order to help speed innovations to market, provide the public with the best health information and ensure the security of regulated products.

With respect to medical devices, the FDA noted its continued focus on the unique device identifier program for keeping an eye on products already on the market.

"With the staged implementation of Unique Device Identifiers over the next 7 years, the information base concerning how marketed devices perform will be stronger than ever, enabling swifter, more targeted actions to ensure continued safety and effectiveness of devices," the agency said. "In addition, the National Medical Device Postmarket Surveillance Plan aims to strengthen the medical device postmarket surveillance system in the United States."

The NMDPS plan, unveiled in April 2013, includes the establishment of the UDI program, the promotion of U.S. and global registries for certain products, updated adverse event reporting systems and new methods for handling evidence.

The FDA plan is still in early stages, and the public is invited to offer comments on the draft through the end of this month.

Here’s a breakdown of the FDA’s strategies for the 2014-2018 period:

Regulatory Science: The FDA plans to develop new testing tools, enhance efficiency in clinical trials and pursue more optimal clinical endpoints to "help FDA reviewers better assess data needs for new products and thus better evaluate new products."

Globalization: The FDA cited several concerns about the ever-increasing globalization of the healthcare market, saying that the number of FDA-regulated shipments has tripled over the last decade. The agency hopes that information-sharing, data-driven risk analytics, enhanced intelligence and "smart allocation of resources through partnerships" will help ensure safety and quality in the supply chain.

Safety and Quality: The FDA will continue to advance the "Case for Quality Initiative," a pilot program enlisting volunteers to help improve compliance and promote medical device quality.

Smart Regulation: The FDA hopes to encourage innovation without sacrificing public safety with initiatives to diminish the threat of lawsuits, level the playing field for new businesses and prevent recalls that could lower public trust and damage industry reputation.

Stewardship: The FDA vowed to keep a close eye on its coffers and limit spending as much as possible, looking for new ways to boost efficiency with its limited resources. "FDA is looking at several projects that will help control costs and streamline operations, while maintaining the integrity of programs upon which the public relies."