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.

GAO: FDA Medical Device Review Timeframes Increasing

A new report from the US Government Accountability Office (GAO) provides yet more data showing that total average review times for FDA 510(k) medical device applications has increased despite the regulator’s meeting other 510(k)-related performance goals.

Specifically, the average total time from 510(k) application submission to final decision increased from 100 days in 2005 to 161 days in 2010—an increase of 61%. However, the report also points out that the FDA has reviewed more than 90% of 510(k) submissions within 90 days each year since 2005; the agency was also able to review 98% of all 510(k) submissions within 150 days. It is important to note that FDA “review times” exclude the time it takes for manufacturers to respond to FDA requests for additional information on their submissions, whereas the total time periods evaluated by the GAO do include time required to respond to additional requests for information from the agency.

Furthermore, the GAO found inconsistencies when it came to FDA reviews of pre-market approval (PMA) applications. For “original” or standard PMAs, the FDA met its performance goals for four out of seven years that those performance goals were in place, but for “expedited” PMAs—available for devices deemed to treat or diagnose life-threatening diseases and meet unmet medical needs—the FDA met its performance goals for only two of the seven years of record.

GAO investigators interviewed industry and consumer advocacy groups as part of its study. Based on these interviews, the report identifies four most common complaints regarding dealing with the FDA for medical device clearances and approvals:

Inadequate communication between FDA reviewers and stakeholders
Lack of predictability and consistency in reviews
Increasing time to final decisions
Insufficient assurance from the FDA regarding devices’ safety and effectiveness

The GAO study clearly breaks no ground in terms of FDA medical device review times—other studies have also come to similar conclusions. What these findings perhaps most importantly demonstrate, however, is the need for manufacturers to make every effort to ensure they do not have to deal with additional requests for information from the regulator.

Markets: USATags: 510(k), 510-k, 510k, FDA, GAO, Government Accountability Office, medical device, PMA, premarket approval

Author: Stewart EisenhartDate: April 2, 2012

GAO Finds FDA Data on Pediatric Devices Lacking

A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use.

The FDA Amendments Act of 2007 (FDAAA), implemented in part to spur development of more medical devices to treat pediatric populations, requires the FDA to identify all devices labeled for use in pediatric patients, and provide annual reports to Congress on the numbers of such devices approved. Although the agency has the capability to identify pediatric devices in its existing internal tracking system, the GAO report contends that the capability has not been consistently used to do so. As such, the FDA’s data on pediatric devices is not reliable or timely, according to the GAO.

GAO reviewers identified 18 devices brought to market either via the FDA’s Humanitarian Device Exemption (HDE) or premarket approval (PMA) process since the FDAAA went into effect; but reviewers also found that indications for use statements for 72% of all devices approved via HDE or PMA had no patient-age-specific information, meaning that additional pediatric devices could be on the US market.

The GAO recommends more consistent use of existing electronic flagging capabilities by FDA personnel in order to better account for the amount of pediatric medical devices marketed in the US.

Markets: USATags: FDA, GAO, HDE, medical device, pediatric medical device, PMA

Author: Stewart EisenhartDate: January 11, 2012

FDA’s Medical Device Recall Process Under Fire from GAO

A new report from the US Government Accountability Office (GAO) has found that the Food and Drug Administration (FDA) has not consistently analyzed medical device recall data to see whether trends in these recalls point to underlying systemic risks.

Examining the FDA’s recall initiations between 2005 and 2009, the GAO found that the agency typically used recall data to monitor individual device recalls and manufacturers, but not to identify broader risks posed by types of devices being recalled.

“Several gaps in the medical device recall process limited firms’ and FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner,” states the report. Some firms affected by high-risk recalls had difficulties locating all devices or device users, due partially to unclear recall oversight procedures at the FDA, according to the GAO.

The GAO lists several problems stemming from this issue:

FDA officials examining similar recall efforts reached opposite conclusions regarding recall effectiveness
The agency has not set criteria for assessing whether firms corrected or removed adequate numbers of recalled devices
FDA decisions to terminate completed recalls were not made within prescribed time frames
FDA officials provided no documented justification for why recalls were terminated

The GAO report provides three recommendations for improving the FDA’s recall process. First, the agency should implement a program to assess medical device recall data on a systematic basis in order to identify strategies to minimize health risks posed by unsafe medical devices.

Second, the FDA should clarify procedures for carrying out recall audit checks in order to ensure that investigators can carry out their tasks more effectively

Third, the agency should set explicit criteria for evaluating the effectiveness of recall efforts carried out by manufacturers.

This new report follows testimony by GAO health care division director Mary Crosse in a US Senate hearing in April in which the director leveled a similar critique of the agency’s recall process.

Markets: USATags: FDA, GAO, medical device, recall

Author: Stewart EisenhartDate: June 23, 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.