Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

US Senate Bill Targets FDA’s Device Review Process

US medical device industry lobbying efforts against current regulatory practices appear to be working. A bill introduced in the US Senate would require the US Food and Drug Administration to expedite medical device review times and subject the agency’s Center for Devices and Radiological Health’s (CDRH) regulatory processes to third-party review to assess their impact on innovation.

The Medical Device Regulatory Improvement Act would amend the Federal Food, Drug and Cosmetic Act in several ways:

Changes to the FDA’s premarket approval process would require reviewers to consider alternative methods of evaluating safety and effectiveness of devices in order to reduce approval time frames and costs, and to consider whether pre-clinical rather than clinical data can be used to determine approval of some devices.
New substantial equivalence determination rules would require the CDRH to focus only on whether a device submitted for clearance has the same intended use as its predicate device and is “as safe and effective as a legally marketed device,” and would forbid reviewers from requesting or accepting data irrelevant to the substantial equivalence determination process. In addition, reviewers should examine device labeling for assessing intended use, and “shall not evaluate issues that do not present a major impact on the intended use as set forth in the labeling.” The bill also would require reviewers to consider alternatives to substantial equivalence evaluations to reduce time and cost of the process.
The bill would also require a management and innovation review at the CDRH 60 days following its implementation. Carried out by a third-party entity, the review would examine all management and regulatory practices at the CDRH to ensure that the unit operates with a clear understanding of how its determinations impact innovation. One year following appointment of the third-party entity to the CDRH review, the entity would submit a report of its findings to Congress.
To address conflicts of interest, the bill would subject all advisory committees providing input to the FDA to provisions of the Ethics in Government Act of 1978 covering federal and special government employees.

Congressional interest in the US medical device regulatory process has increased steadily over the past several months. If it becomes law, this bill would stand as a substantial victory for industry advocates arguing that the FDA’s review process has hurt medical device manufacturers.

Markets: USATags: 510(k), 510k, FDA, medical device, Medical Device Regulatory Improvement Act, Senate

Author: Stewart EisenhartDate: October 14, 2011

House Republicans Propose 12% Cut to FDA Budget

The US House of Representatives’ Appropriations Committee has issued a 2012 spending bill cutting the Food and Drug Administration’s budget by $285 million, or 11.5%.

According to The Hill and MassDevice.com, such cuts could significantly impact the agency’s plans for implementing more robust 510(k) clearance processes, as well as affect reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) next year.

If enacted, the budget cut could also prompt the FDA to raise fees it charges to medical device and pharmaceutical firms for reviews and product approvals.

The spending bill’s passage remains far from certain, however; it must win approval by the whole House and then survive the Democratic Senate and avoid a presidential veto.

Markets: USATags: Budget, FDA, House of Representatives, MDUFMA, Medical Device User Fee and Modernization Act, Senate

Author: Stewart EisenhartDate: May 27, 2011

GAO Finds FDA’s Review and Safety Processes Inadequate

In April 13 testimony before the US Senate’s Special Committee on Aging, Government Accountability Office (GAO) health care division director Mary Crosse raised substantial doubts about the Food and Drug Administration’s (FDA) oversight of medical devices.

Crosse’s testimony was based on evaluations of steps the FDA has taken since a set of recommendations issued by the GAO in early 2009 to improve the regulator’s premarket review process; the GAO had expressed particular concern regarding the FDA’s practice of clearing some Class III devices through the 510(k) process. Acknowledging that the agency has rolled out strategic goals to phase out this practice, Crosse noted that 26 Class III device types can still gain clearance for sale in the US via 510(k) rather than premarket approval (PMA).

“Since we issued our report in January 2009, FDA cleared at least 67 individual submissions that fall within 12 of these Class III device types through the 510(k) process,” Crosse said in prepared statements.

The FDA’s handling of recalls also garnered poor reviews from the GAO director.

“Our preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented inan effective and timely manner,” Crosse stated. “These shortcomings span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”

Crosse went on to cite alarming examples of high-risk devices slipping through the cracks of the FDA’s recall process.

While the FDA has come under fire from all sides in recent months, this new GAO critique does not fit neatly alongside arguments from the medical device industry that the agency’s review process has become too onerous, and that a revised 510(k) process would impede efficient introduction of cutting-edge devices into the US market. Both the GAO and industry arguments emphasize more consistency in how the FDA applies and enforces its regulations, but the evidence supplied by Crosse points in the direction of more robust review and post-market surveillance systems, while industry groups continue to push for efficiency and speed to market.