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 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 Guidance on HUD Designations Out for Comment

The US Food and Drug Administration has opened a 90-day comment period for draft guidance on Humanitarian Use Device (HUD) designations.

The HUD designation program, run by the Office of Orphan Products Development (OOPD), enables qualifying medical devices to be considered for marketing approval via a Humanitarian Device Exemption (HDE) application. HDE applications are similar to premarket approval applications, but do not require manufacturers to demonstrate reasonable assurances of effectiveness.

The draft guidance covers the following HUD-related issues:

Demonstrating that the device seeking HUD designation targets diseases affecting less than 4,000 people annually in the US
Variations of that demonstration depending on whether the device is designed for therapeutic or diagnostic use
How device properties affect that demonstration
Definition of a plausible patient population for the disease in question

Interested parties have 90 days to submit comments on the FDA’s proposals.

Markets: USATags: FDA, HDE, HUD, Humanitarian Device Exemption, Humanitarian Use Device, PMA, premarket approval

Author: Stewart EisenhartDate: December 14, 2011

New Guidance from FDA on 30-Day Notices

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued new guidance regarding when medical device firms should issue 30-day notices for manufacturing changes.

The guidance also explains which manufacturing changes instead warrant 135-day premarket approval (PMA) or 75-day Humanitarian Device Exemption (HDE) supplements.

Manufacturing changes that qualify for 30-day notices pertain to changes in manufacturing methods and procedures—unless those changes affect product performance or design specifications, or alter the device’s physical or chemical specifications. In those instances, manufacturers should provide 180-day PMA supplements or 75-day HDE supplements as appropriate.

Examples of manufacturing changes warranting 30-day notice include:

Sterilization process parameters
Automation of an existing manufacturing process
Joining processes
Cleaning methods for manufacturing material removal
Changes in manufacturing materials such as machine lubricants and soldering flux

Furthermore, such changes should be submitted as 30-day notices only if they’re considered critical to device performance; otherwise, manufacturers should document these changes in their periodic or annual reports.

Changes that do not qualify for 30-day notices include those to manufacturing or sterilization sites of finished devices; to design or performance specifications; to material specifications; or to device operating software.

Once a manufacture has submitted notice, the firm may resume distributing the device in question after the 30-day notice period unless contacted by the FDA for further information.

The CDRH is accepting public comment on the guidance at any time.

Markets: USATags: CDRH, Center for Diseases and Radiological Devices, FDA, HDE, medical device, PMA

Author: Stewart EisenhartDate: April 21, 2011