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.

Device Recall Regulations Set to Take Effect in China

China’s State Food and Drug Administration (SFDA) will implement new medical device recall regulations on July 1.

The Provisions for Medical Device Recall (interim) include 38 articles covering the supervisory system for device recalls, classification and categories of recalls as well as legal liability issues. The provisions are intended to hew closely to international conventions regarding core issues, and incorporate procedures already put in place for China’s drug recall system. Also included in the provisions are more specialized regulations to better target issues surrounding medical devices.

Markets: ChinaTags: China, medical device, recall, SFDA

Author: Stewart EisenhartDate: June 23, 2011

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

Recall Study Results Suggest 510(k) Reform Needed

A new study examining high-risk recall rates of medical devices in the US has added weight to contentions that the Food and Drug Administration’s 510(k) clearance process needs strengthening.

Industry advocates including the Advanced Medical Technology Association (AdvaMed) have wasted no time decrying the study’s methodology and results. But that should prove hardly surprising given how doggedly AdvaMed has pushed against any moves to make the 510(k) process more rigorous.

The study, available on the Archive of Internal Medicine’s website, assessed 113 serious medical device recalls made between 2005 and 2009 using data available on the FDA website; researchers found that only 21 of those recalled products had gone through the FDA’s stringent premarket approval (PMA) process, while 80 of those products had obtained less strict 510(k) clearances and eight additional products had been exempted from FDA review.

Of the largest category of recalled devices—cardiovascular products—two-thirds of those devices had earned 510(k) clearances. Acknowledging (and anticipating) arguments made by (AdvaMed) that the number of 510(k)-cleared devices recalled between 2005 and 2009 constitute a small percentage of products cleared through premarket notification, study authors Diana Zuckerman, Paul Brown and Steven Nissen posit that such statistics do not take into account the impact of such recalls on public health. If the FDA continues to rely on the 510(k) process to clear devices for the US market, they argue, then that process must more vigorously assess those devices before commercialization.

The study also recommends four changes to the FDA review process to reduce future recalls. First, the FDA should fully implement current law requiring submission of all Class III devices to the PMA process. Second, FDA definitions of high-risk devices should include potential risks of those devices’ failures. Third, the FDA should inspect 510(k) device manufacturing as the agency currently does for PMA devices. Finally, the agency should apply the same special controls in place for PMA devices—postmarket surveillance, performance standards and general-guidance documents—to 510(k) devices.

Markets: USACategories: Regulatory ComplianceTags: 510(k), advamed, FDA, PMA, recall

Author: Stewart EisenhartDate: February 15, 2011