FDA Releases Changes to the 510(k) Program; Shuren Bids Farewell to His Second-in-Command Spot at the FDA

FDA Releases Changes to the 510(k) Program; Shuren Bids Farewell to His Second-in-Command Spot at the FDA

The wait is over. After sitting through countless meetings (throughout the country, no less) and scouring dozens of comments from medical device industry representatives, the U.S. Food and Drug Administration (FDA) recently unveiled 25 changes to its highly criticized 510(k) program, promising to transform the procedure into a more transparent, efficient process.

The agency temporarily deferred its most controversial reforms, preferring to wait for the Institute of Medicine to release its own review of the 510(k) program this summer before making a final decision on their fate (the ability to revoke 510(k) clearances, requiring increased post-market surveillance and establishing a new device classification system that would require the submission of clinical data are among the most unpopular proposals).

The decision to sidestep the controversial recommendations included in its report from last summer reflects a cautious approach by the agency’s leaders, Commissioner Margaret Hamburg, M.D., and Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). The FDA received more than 76 public comments after it released the report, many of which opposed the changes from various standpoints.

Nevertheless, there are plenty of changes coming this year. To facilitate innovation in the medical technology industry, the CDRH plans to streamline the “de novo” process (typically reserved for innovative, lower-risk products) and publish guidance on product modifications and clinical trial data. The agency is hoping to deliver by September a 510(k) “paradigm” guidance that would include information on ways in which companies could use multiple predicates, the types of applications that would require clinical trial data, and a clear definition of “intended use.”

The CDRH also plans to develop a network of external experts to help the agency address scientific issues about new medical device technologies. In addition, the CDRH intends to create a new Center Science Council to guide the agency in science-based decision-making.

Other changes to the FDA’s 510(k)device evaluation program include:

• Developing unique product codes;

• Developing additional guidance on pre-investigational device exemption (IDE) meetings and enhancing the quality of pre-submission interactions between device companies and CDRH staff;

• Training new CDRH staff on core competencies, and improving knowledge management throughout the center;

• Exploring the use of an “assurance case” framework for 510(k) submissions;

• Developing better data sources, methods and tools for collecting and analyzing postmarket information, and enhancing the CDRH’s capabilities to support evidence synthesis and quantitative decision making;

• Clarifying and more quickly informing device companies as well as industry stakeholders about changes to the CDRH’s regulatory expectations;

• Assessing, differentiating and mitigating challenges in reviewing IDEs;

• Developing a process to regularly evaluate the list of device types eligible for third-party review and enhancing third-party reviewer training;

• Improving the recording of 510(k) transfers of ownership; and

• Clarifying statutory listing requirements for submitting product labels.

Shuren said the 510(k) changes will lead to a “smarter” medical device program that supports innovation, retains jobs, and quickly brings safe and effective technologies to patients.

“Facilitating innovation is a critical part of the agency’s responsibility to promote the public health, but this can happen only if the U.S. can support a robust, innovative medical device industry,” Shuren wrote in a letter that accompanied the 510(k) changes. “The steps we are announcing remove roadblocks to innovation while protecting patient safety.”

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), called the FDA’s planned changes to its 510(k) program “a good first step” but noted that implementation of the plan will be critical.

“Much of the agency’s plan supports our long-standing position that the 510(k) process is fundamentally sound and has been beneficial to American patients. The plan also generally adheres to our principles that any changes to the 510(k) process should be targeted, have a corresponding health benefit and support timely access to new treatments and cures,” Ubl said. “The critical next step is how FDA implements the plan through guidances and regulations. Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.”

Approximately 3,500 devices are cleared each year under the 510(k) program, according to the FDA. More than 90 percent of device approvals between 2003 and 2007 came through the 510(k) program. The program was created in 1976 as part of the Medical Device Amendments.

Consumer advocates, not surprisingly, were less pleased with the changes. Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA’s apparent concessions mean that “industry lobbyists won, and the public lost,” the Associated Press reported.

“The FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments,” Zuckerman said.

The unveiling of changes to the FDA’s 510(k) program comes on the heels of a report from consulting firm PricewaterhouseCoopers LLP that warned that the United States may be losing ground to emerging markets in medical technology innovation.

Many medical device industry leaders have said, while maintaining that the current system ensures patient safety, that an increasingly burdensome regulatory pathway would make it harder for U.S. companies to compete globally and maintain the competitive advantage it has enjoyed for years.

“The fact that [the FDA is] not going to take on more than they should right now, and deferring some of the tougher proposed changes to the appropriate guidance process, was a constructive outcome,” said Bill Hawkins, chief executive officer of Minneapolis, Minn.-based Medtronic Inc. “This is a more balanced approach that sends a positive signal to industry that the FDA is engaged, listening and concerned.”

For a complete look at all the changes the FDA plans for the 510(k) process,visit the agency’s website at: www.fda.gov/MedicalDevices/ucm239448.htm

FDA Loses its Secondin Command

The U.S. Food and Drug Administration (FDA) is losing one of its key leaders. Deputy Commissioner Joshua Sharfstein reportedly is leaving the agency to take the top public health job in the state of Maryland.

Maryland Gov. Martin O’Malley confirmed Sharfstein’s appointment as secretary of health and mental hygiene. His start date was Jan. 12.

Sharfstein replaces John Colmers, who has led the Old Line State’s health agency since 2007. The governor credited Colmers and his own administration for expanding healthcare coverage to nearly 243,000 Maryland residents over the last three years. During Colmers’ tenure, Maryland also recorded the lowest infant mortality rate and increased access to dental care for low-income children through the Deamonte Driver project.

Sharfstein said Colmer’s accomplishments will give him a “terrific foundation” for further progress. “It is a special honor to serve my state at such a critical time for healthcare and public health,” he said in prepared remarks.

FDA officials, meanwhile, moved quickly to replace Sharfstein, if only temporarily. Authorities named John Taylor, former director of the Office of Enforcement and a counselor to FDA Commissioner Margaret Hamburg, M.D., as FDA Deputy Commissioner for the next 60 days. Officials plan to decide over the next two months whether Sharfstein’s position should be filled (and if so, how to fill it).

The FDA, however, had no official comment on Sharfstein’s resignation.

A doctor and researcher, Sharfstein was public health director for Baltimore, Md., before he became the second in command at the FDA. He also had worked on Capitol Hill for U.S. Rep. Henry Waxman (D-Calif.) as an aide. He started his tenure at the FDA in March 2009 and immediately focused on investigating the December 2008 approval of the Menaflex Collagen Scaffold for repairing and reinforcing meniscal tissue in the knee. The surgical mesh, manufactured by Hackensack, N.J.-based ReGen Biologics Inc., is designed to stimulate the growth of new meniscal tissue in damaged knees.

At the end of Sharfstein’s investigation in 2009, the FDA decided to review the approval for Menaflex as well as the agency’s approval standards for all medical devices. The FDA okayed Menaflex under a fast-track approval process known as 510(k). Last fall, the FDA revoked approval for the Menaflex Scaffold, claiming it should not have been cleared by the agency.

Sharfstein’s stint at the FDA was brief, but productive. He not only helped shape the leadership but also pushed for stronger safety standards for medical devices and better compliance by pharmaceutical firms. With both he and Hamburg at the helm of the FDA, the agency has become more aggressive in regulatory matters, issuing more warning letters to companies for manufacturing and marketing violations with less negotiation time. The FDA also has begun targeting individual employees of drug companies in criminal and civil investigations, including company lawyers.

John Manthei, a partner at global law firm Latham & Watkins LLC called Sharfstein’s resignation a key loss for the FDA and said the agency’s remaining leaders must decide on the kind of role they want his replacement to undertake. “Josh has been very active and he’s been a key player at the FDA for the last few years,” Manthei told Medical Product Outsourcing. “I think it’s going to be interesting to see the kind of role his replacement is going to play. Is the person going to continue to drive policy as Josh did, or will this person work toward implementing the policies that have been set forth by the agency over the last few years? It’s going to be interesting to see what is decided.”

Orthopedic Industry Could be in GOP Lawmaker’s Crosshairs

One top Republican in the U.S. House of Representatives is targeting the orthopedic industry. For people who think the medical device industry might get a better deal from a Republican Congress, this could make them think again. Rep. Darrell Issa of California is the newly appointed chairman of the powerful House Oversight and Government Committee. In early December, he told The Wall Street Journal that he wants to cut Medicare spending on orthopedic devices that doctors overuse.

According to Issa, his own doctor informed him that surgeons have an incentive under Medicare to implant many joint and bone screws to support patients’ spines, when fewer implants, or perhaps none at all, might be equally effective and safer.

“They have got to come up with a system that doesn’t reward people for putting more metal in somebody’s spine,” Issa told the WSJ. “My committee can help by looking at whether the government is answering and informing about the lowest-cost, least-invasive procedures.”

Issa said it might be time for the Centers for Medicare and Medicaid Services to consider cost-effectiveness in coverage decisions for medical devices, as long as the decisions are made by physicians rather than government “bureaucrats.” In the past, Republicans have been opposed to government panels making cost-effectiveness decisions, but Issa seemed to be okay with medical panels made up of “people who care about what’s best for their patients.”