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

Agency Announces Five Key Priorities over Next Five Years

Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan that could have far-reaching consequences for the medical device industry.

In late April 2011, FDA Commissioner Margaret Hamburg and her staff released a 50-page report on FDA’s Strategic Priorities, 2011-2015: Responding to the Public Health Challenges of the 21st Century. The report outlines five goals and accompanying actions that cut across all types of FDA-regulated products. In addition, the report sets two more goals specifically targeting the medical device industry.

FDA’s five cross-cutting priorities over the next five years include:

  1. Advance regulatory science and innovation
  2. Strengthen the safety and integrity of the global supply chain
  3. Strengthen compliance and enforcement activities to support public health
  4. Address the unmet public health needs of special populations, and
  5. Advance medical countermeasures and emergency preparedness

The theme running throughout the entire strategic plan is the agency’s renewed focus on regulatory science and innovation. “Science underlies everything we do at this agency, and to serve the public health we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe and effective products and life-saving therapies for the people who need them most,” the Commissioner says.

Let’s examine where these priorities intersect the interests of the device industry.


 

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.


Priority #4: Address Health Needs of Special Populations

In discussing its fourth priority, FDA says there are many vulnerable and underserved populations that deserve special attention from regulators and the public health community. It especially singles out women, minorities and children as underrepresented in clinical trials.

The agency expresses concern that medical devices often are not tested in or sized for a relevant pediatric population. It also would like to see the industry make additional efforts to understand the long-term safety of devices used chronically in children. Over the next five years, FDA plans to expand its research efforts, grant and communication programs and international collaborative efforts to reach out to these special populations and encourage industry to do the same.

Priority #5: Advance Medical Countermeasures

Regarding its fifth strategic priority, FDA admits the U.S. still does not have the range of medical countermeasures (MCMs) needed to effectively respond to a chemical, biological, radiological or nuclear attack or infectious disease outbreak. The agency says there are not enough FDA-approved MCMs such as vaccines, diagnostic tests and personal protective equipment to respond to these types of public health emergencies.

Going forward, FDA is developing an MCM action plan with three main efforts:

1) Upgrade the MCM review and approval process by building multidisciplinary public health and security action teams.

2) Advance regulatory science for MCM development and evaluation through internal and collaborative external research. FDA’s goal is to identify situations where the application of new science could simplify or speed product development and/or the regulatory process.

3) Optimize and, if needed, overhaul the legal, regulatory and policy framework for effectively responding to public health emergencies.

Industry Specific Priority: Advance Medical Device Safety and Effectiveness

A summary of FDA’s long-term objectives for medical devices appears below.

A summary of FDA’s long-term objectives for medical devices appears below.


Beyond the five strategic priorities that impact all FDA-regulated products, the new FDA report specifically cites two more focal points for its device program:

1)  Improving the quality, consistency and predictability of regulatory decision-making, and

2)  Facilitating medical device innovation

The agency plans to take a total product life cycle approach to regulating the medical device industry – from development and design through obsolescence. As part of its effort to strengthen its device premarket review programs, FDA completed a comprehensive assessment of the 510(k) program and its use of science in regulatory decision-making.

In August 2010, the agency released its findings and recommendations in two reports, “CDRH Preliminary Internal Evaluations (Volumes I and II).” FDA solicited feedback on the reports at two public meetings, three town hall meetings, three open public dockets and several meetings with individual stakeholders.

Based upon feedback from the device industry and the concerns it expressed about being able to innovate under new rules, FDA announced in May 2011 that it would:

  • Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency
  • Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies
  • Establish a new Center Science Council of senior FDA experts within CDRH to foster more timely and consistent science-based decision making

While encouraging innovation, FDA says that it must not stray from its equally important mission of ensuring safe devices. Accordingly, the agency plans to:

  • Establish a public database of important device information, such as labeling and summaries of the basis for FDA’s decisions to clear specific devices
  • Require device manufacturers to provide a brief description of scientific information regarding known safety and effectiveness issues for select high-risk devices

Meanwhile, the device industry awaits the recommendations from the Institute of Medicine, which is conducting an independent evaluation of the 510(k) program. Published reports from April 2011 show that the Institute has completed its internal review and is now soliciting comments from the industry. The Institute report is expected later this summer, while the entire FDA five-year strategic report can be accessed now from the agency’s website.

Responding to these Initiatives: Suggestions for Industry

What does FDA’s five-year plan mean to the medical device industry – now and in the future? I would suggest companies use this time – while the agency is deciding how best to meet these priorities – to “get ahead of the curve.” We all know that change at FDA can be slow, but as a 22-year veteran of the agency, I am confident in saying that many of these changes are inevitable.


I suggest you gather the highest levels of your management together and conduct a thorough and honest appraisal of your following activities:

1. Supplier Selection and Control

FDA holds management, not the quality assurance department, responsible when outsourcing decisions go bad. Anything and everything can be outsourced, except responsibility. Review your policies, Standard Operating Procedures and even your corporate culture to ensure that you have integrated supplier selection and control throughout your quality program.

Don’t just periodically audit your suppliers; monitor them continuously – just as you would any other critical manufacturing process. All too often, when a company outsources a process or a component, it reduces its quality assurance staff, assuming that the supplier will handle those responsibilities. But in reality, the more you outsource, the more you need a vigorous and vigilant quality assurance department. Monitoring an outsourced operation can be far more difficult and time-consuming than monitoring any internal operation.

2. Inspection Preparedness and Response

Understand there will be heightened oversight of your operations – worldwide. The most obvious evidence of this oversight will be inspections, not all of them directly conducted by FDA. There will be better local, national and international coordination of inspection strategies and more sharing of inspection results. You’ll see more “corporate initiatives,” meaning that FDA will undertake coordinated inspections of multiple manufacturing sites, looking for common quality control problems that may cut across diverse product lines.

One of the tools to use to improve your inspection readiness is FDA’s own publicly available Investigations Operations Manual, a collection of agency policies, guidelines and checklists used by FDA field investigators. With this manual in mind, EduQuest has written an Advisory on “Using FDA’s Own Playbook to Prepare for Your Next Inspection,” available by contacting me via This email address is being protected from spambots. You need JavaScript enabled to view it..

3. Documentation

FDA will continue to place a high priority on documentation. The agency’s unstated motto is, “If it isn’t documented, it isn’t done.” So document everything associated with your product decisions. Have those documents easily accessible for your own staff and for FDA inspectors.

In the past 30 years, I’ve audited literally hundreds of device design, manufacturing and distribution facilities around the world and found that documentation is universally poor. Everyone loses design records and other key documents, and just about everyone fails to record (i.e, document) key product decisions and justifications. But understand that poor documentation is low-hanging fruit for agency inspectors. It also makes for embarrassing and share-price deflating fodder for the news media when the information gets out (as it inevitably does).


4. Risk Management of Your Product’s Life Cycle

Understand the agency’s expectations for risk management and incorporate them in all of your decisions – business as well as scientific. Factor risk management into the very initial stages of your product design, and carry it through to post-market surveillance. Expect that Medical Device Reporting, recalls, and device advertising will attract more agency attention and enforcement resources.

5. New Product Development and Scientific Support

Monitor FDA’s actions on the 510(k) program closely, including its response when the new Institute of Medicine report is released. Make your voice heard whenever possible. But be prepared that most likely, as a tradeoff for more expeditious agency reviews, you will need to share with the agency and eventually the public more scientific information about your product than ever before.

Increasingly, the information you develop and share will need to be standardized. Get involved now with industry trade groups and standard-setting bodies so you can participate in the decisions and get a head-start on adapting your internal systems to the evolving standards.

If you have especially cutting-edge products or emergency MCMs, look for opportunities to collaborate with the agency either directly or through third-parties such as academia. FDA wants your product to succeed, but you have to do your part in establishing and documenting solid scientific evidence of its safety and effectiveness.

REFERENCES

FDA’s Strategic Priorities, 2011-2015: Responding to the Public Health Challenges of the 21st Century.
www.fda.gov/aboutfda/reportsmanualsforms/reports/ucm227527.htm

FDA’s Investigations Operations Manual.
www.fda.gov/ICECI/Inspections/IOM/default.htm

Martin Browning is the President and Co-Founder of EduQuest, a global team of FDA compliance experts based near Washington, D.C. He spent 22 years with FDA as a local, national and international expert investigator, then served as special assistant to the Associate Commissioner for Regulatory Affairs. He also was the vice chair of the agency’s Electronic Records and Signatures Working Group, which drafted the 21 CFR Part 11 regulations. Martin served as the chair of the U.S. government’s ISO 9000 committee; on the Global Harmonization Task Force, and on the committee that developed the Good Manufacturing Practice regulations for medical devices, otherwise known as the Quality System Regulation (QSR).

He is the program chairman of EduQuest’s popular training courses, including “QSR Compliance Fundamentals,” “Design Control for Medical Devices,” “FDA Auditing of Computerized Systems and Part 11” and “The CAPA Clinic: Effective CAPA Systems and Failure Investigations,” all offered globally. Details are available at www.EduQuest.net.Comments and questions about this article can be addressed to Martin Browning in care of This email address is being protected from spambots. You need JavaScript enabled to view it..

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