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.

New FDA Guidance Targets Pediatric Exposure to X-Ray Devices

The US Food and Drug Administration is planning new premarket notification requirements for manufacturers of X-ray imaging systems used on pediatric patients.

New agency guidance argues that the general indications for use most X-ray devices currently provide on the US market do not address particular concerns regarding higher sensitivity of pediatric patients to effects of radiation emitted by these devices. If enacted into law, the new guidance could impact not only 510(k) submission requirements, but also device design issues and labeling for manufacturers whose products fall under the new proposal.

According to the guidance, manufacturers seeking 510(k) clearance for new X-ray imaging devices must either provide additional data to support safety and effectiveness in pediatric populations, or provide warning labels for their products if they intend only to target adult populations following FDA clearance.

Information that new rules would require manufacturers to include in their 510(k) premarket notification applications include clear definitions of indications for use for pediatric patients; device descriptions explaining device design features for pediatric patients; and risk assessment data that includes risks specific to pediatric populations.

Pediatric-appropriate protocols, laboratory image quality and dose assessments, and clinical image quality assessments pertaining to pediatric populations should also be included.

The FDA is accepting public comment on the guidance over the next 120 days.

Markets: USATags: 501(k), 510k, FDA, imaging system, medical device, pediatric medical device, x-ray

Author: Stewart EisenhartDate: May 10, 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