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The Office of Device Evaluation annual report released Monday shows that CDRH was much faster in reviewing PMAs in fiscal year 2006 than in FY 2005, Reuters reports. The report attributed the improvement — PMA reviews dropped from an average of 438 days in FY ‘05 to an average of 335 days in FY ‘06 — to reforms implemented from the Medical Device User Fee and Modernization Act of 2002. Statistics for FY 2007 are not yet available.

However, average 510(k) review time rose slightly, from 87 days in FY ‘05 to 95 days in FY ‘06. And the report also noted that third-party reviews dropped in 2007, compared to 2006. That was before reforms to the program included in the FDA Amendments Act of 2007 were implemented, though.

– From MD&DI’s blog.

The House has passed a bill that would add $150 million to FDA’s budget for more staff and more inspections of foreign plants making devices, drugs, and food for U.S. consumption, the Associated Press reports. The FDA provision was tucked in to a bill that would provide an additional $162 billion in funds for the wars in Iraq and Afghanistan. It falls short, however, of the $275 million the Bush Administration requested and the Senate authorized earlier this month. The difference will have to be reconciled in a bill conference.

CDRH’s new interactive review scheme is intended to prevent unnecessary delays in the completion of PMA and 510(k) reviews, Office of Device Evaluation director Donna-Bea Tillman said at a recent conference. It was also established to avoid surprises at the end of the review process, minimize the number of review cycles, and ensure timely responses from sponsors, she told those attending the Medical Device Manufacturers annual meeting on June 12.

While informal dialogue has always been a part of the review process, it is now institutionalized, she said. An industry complaint about the MDUFMA review goals followed from 2002 to 2007 was that the scheme did not give reviewers enough time or flexibility to interact informally with applicants.

The new scheme allows FDA to interact informally with applicants to resolve outstanding issues in a timely manner, Tillman said. For 510(k)s, it can pertain to any outstanding issues. For PMAs, it pertains to issues that can be resolved without substantive review or analysis. Examples include administrative items, device drawings that need more detail, labeling revisions, clarification of clinical data or test methods and results, and post-approval study plans.

“Say you have a software issue,” she said. “We will alert you to this error so you can get started working on it. That will help you prepare and submit a response in a timely manner.”

The timeframe for a response will be agreed upon when FDA contacts the applicant about the issue(s), she said. It is very important that industry provide complete responses to all deficiencies communicated during the review within negotiated timeframes, “even if you don’t agree with the question,” she noted. Otherwise, the application risks being placed on hold. Industry also must not use the program to request status updates; those just cause delays, she explained.

– From MD&DI’s blog.

There has been no policy decision made at CDRH that would require more data to accompany 510(k) submissions, center director Daniel Schultz told a questioner at an FDLI annual meeting session in March.

“We need better data for more-complex 510(k) products,” he said. “We can’t review very complex products, often with numerous software changes, in the same way as we would products with only two moving parts.” He said that CDRH will continue to take a risk-based approach to data requirements, asking for all necessary data to conduct adequate reviews.

Earlier, in a presentation on CDRH activities, Schultz said the center is now able to track every medical device postmarket study that has been required of sponsors, that is currently under way, or that has been completed. This was not the case in the past.

Moreover, Schultz said, CDRH has improved its postmarket monitoring ability with the creation of a surveillance matrix, or “network system.” It is designed around several device categories, including cardiac, orthopedic, and ophthalmic devices; radiological products; and neurology, anesthesia, and respiratory equipment.

Improvements have also been made to the MedSun surveillance system, Schultz said, enhancing CDRH’s ability to gather and interpret information on adverse events associated with the use of medical devices. He indicated that adverse-event reports from hospital labs and other MedSun reporting sites are often received electronically, which has improved the center’s ability to spot postmarket problems quickly and to analyze trends in device use.

Schultz also said that CDRH has started developing a unique-device identification system regulation, which will assist in identifying and, if necessary, recalling problematic devices, as mandated by the FDA Amendments Act of 2007.

Schultz said modernization of CDRH’s information technology (IT) capabilities is well under way. He explained that the center is able to use a common FDA electronic portal, or gateway, for receiving adverse-event reports, with incoming reports automatically directed to the appropriate FDA centers for action or review. How important is robust IT? Just consider the volume of work flowing through the center. It receives more than 9000 premarket submissions each year, comprising more than 3 million pages. There are now 40 million pages residing in the center’s computerized IMAGE system.

– James G. Dickinson

FDA should have some level of oversight for all laboratory tests, including the more than 1100 genetic tests now offered by hundreds of laboratories across the nation, according to an HHS advisory committee report.

The committee voted recently that the gap in oversight of the clinical validity of these tests should be closed as quickly as possible. The final report from the Secretary’s Advisory Committee on Genetics, Health, and Society was written in response to a charge from HHS secretary Michael Leavitt to examine the need for genetic testing oversight. It calls for a number of actions in various HHS agencies to beef up information-gathering and regulation of the tests.

The recommended FDA oversight is a huge undertaking, committee members recognized, and it will require “commitment of significant resources” to avoid harming patients and to avoid stifling technological innovations. According to the committee’s draft report, FDA has cleared or approved fewer than 100 genetic tests so far.

A key issue in committee discussions was whether there should be a difference in regulatory oversight for in vitro diagnostics (IVDs), which are developed by manufacturers for distribution to numerous labs after FDA clearance or approval, and oversight for laboratory-developed tests (LDTs), which are developed for use solely in the developer’s laboratory. The report notes that only recently has FDA exercised regulatory authority over LDTs.

For the most part, LDT regulation has been left to regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the report says. Overseen by the Centers for Medicare and Medicaid Services (CMS), CLIA requires all clinical laboratories to be inspected for standards compliance. The secretary’s committee says that is not enough, although some committee members did voice concern that it would slow innovation if laboratories were to go through the same level of FDA regulation as IVDs. The committee decided that from a patient’s viewpoint, the question of whether a test is an LDT or IVD is not a priority.

Steven Gutman, CDRH’s director of IVD device evaluation and safety and also an ex officio committee member, said that patients simply want a test to work. They also want someone other than the sponsor to be responsible for saying that it works.

The committee discussed how to prioritize tests for oversight according to the risks they pose to patients—especially in light of the huge number of LDTs, many of which may be exotic and rare, according to Gutman. The panel finally recommended that HHS convene a multistakeholder group from the public and private sectors to determine the criteria for risk certification of tests. The group would also be tasked with developing a process for systematically applying such criteria.

In another major recommendation, the committee indicated that a yet-to-be-determined federal agency should create a mandatory, Web-based database of all tests. The committee discussed whether such a database should be at the Centers for Disease Control and Prevention, CMS, or FDA. However, in light of the practical and legal questions, the committee said HHS should appoint and fund a lead agency to develop the database, maintain it, and to work closely with its sister agencies on it.

FDA should engage other agencies and prepare a guidance document on its authority to regulate clinical support systems, the committee said. The guidance should “explain in particular which features of the system constitute a device” as the term is used under FDA authority.

The recommendations also said that FDA, among other federal agencies, should strengthen its monitoring and enforcement efforts against labs and companies that make false and misleading claims about genetic tests.

In addition, the committee stated its concern about certain types of genetic tests that are marketed directly to consumers, especially about the insufficient oversight of the labs offering them. The committee said that CLIA’s authority, along with FDA’s risk-based regulatory authority and processes, should be expanded to encompass the full range of health-related genetic tests.

It also noted that although “FDA has asserted its authority over clinical decisions support systems, the extent to which the agency intends to regulate such systems is not clear. Given that [such] systems will be necessary to communicate information appropriately in the pre- and postanalytic period, and because these systems contain elements that involve the practice of medicine, clarification of the nature and scope of FDA oversight of such support systems is critical.”

– James G. Dickinson

Sometimes good intentions lead to bad policy. Unfortunately for the medical device industry, that appears to be the case with the first draft of the FDA Globalization Act, about which Congress heard testimony in May.

After a Government Accountability Office report revealed that FDA is incredibly far behind on its efforts to inspect foreign plants that make medical devices for U.S. consumption, it became clear that reform is needed. At the current level of staffing and funding, it would take 27 years for the agency to get to them all. The numbers for foreign food and drug plants are similarly unacceptable.

The bill would boost funding for the agency’s foreign inspection operations and set up some permanent agency offices in foreign lands. These steps are much needed. But some of the other provisions in the first draft of the bill are problematic. They have the potential to place significant burdens on industry and stretch the agency even thinner than it is now.

The most egregious is a provision that would require FDA to conduct preapproval inspections of all Class II devices. Currently, preapproval inspections are required only for Class III/PMA devices.

The thing is, only about 50 PMA devices get approved each year, yet scheduling preapproval inspections for them is a train wreck. Consider what Wally Pellerite, a veteran of CDRH’s Office of Compliance, told us in 2005:

“Industry goes through the review process, the scientific questions are answered, and then the district goes out to conduct the inspection. The reviewers routinely find that the firms are not ready. Maybe the firms won’t be ready for four to eight months. The manufacturing process is not established to a point where it can be inspected. And then when firms are ready, they expect the district to get right to it… It’s a significant issue that places a lot of burden on the districts.”

If the process is difficult to coordinate 50 times a year, consider that more than 3600 Class II devices are cleared each year. Even with the increased resources Congress wants to give the agency, trying to schedule an additional 3600 inspections a year would be a disaster.

The requirement would “bring the FDA approval process to a screeching halt,” AdvaMed president Stephen J. Ubl told the House Energy and Commerce subcommittee during its hearing on the bill. He’s right. There is no evidence that the measure would help public health, and there is potential that it could harm public health by delaying patient access to new products. It needs to be dropped from the legislation immediately.

Also problematic is a provision that would require each plant making Class II products to be inspected within two years, regardless of its track record or the level of risk the products produced there. FDA moved away from this strategy for domestic inspections for a reason: It made no sense to inspect low-risk devices as often as high-risk devices, given the agency’s resources. This principle holds true even though FDA will likely be getting more resources. Public health is still better served by more-frequent scrutiny of high-risk products. Not all medical devices are created equal, yet the legislation seems to assume they are.

Another stumbling block is language that would impose a broad-based facility user fee to help pay for more-frequent foreign and domestic inspections. In his testimony, Ubl objected to it strenuously. He said funding via user fees could have unintended consequences, such as small device firms with no overseas operations unwittingly funding inspections for larger competitors that do operate overseas. Instead, he said, Congress should create “a targeted funding mechanism for inspections of foreign facilities that are located in countries with less-developed regulatory systems and actually export products to the United States.”

The idea behind the bill is a good one, but parts of it will create more problems than they solve. The medical device industry must let Congress know, loudly and frequently, that those portions need to be scrapped.

– Erik Swain