FDA Proposal Will Require Additional Testing Requirements for AEDs
| Printer friendly version
The FDA issued a proposed order on March 22nd that, if finalized, could potentially toughen the approval process for manufacturers of automated external defibrillators (AEDs). Under the proposed order, manufacturers will now be required to submit a pre-market approval application (PMA) or notice of completion of a product development protocol (PDP). AEDs are used to prevent cardiac arrest in patients by delivering an electrical shock to re-establish normal cardiac rhythms. According to an article by The New York Times reporting on the proposed order:
There have been 45,000 reports of the devices failing or malfunctioning since 2005. . . . The vast majority of them were due to manufacturing problems, . . . but some were because of improper maintenance, like battery failure. Manufacturers have recalled the devices 88 times in that period.
The article notes that while the new regulations would typically require manufacturers to conduct expensive and time-consuming clinical trials, many of the nine U.S. manufacturers of AEDs have already collected the necessary data, according to Dr. William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health. For these manufacturers, Dr. Maisel stated that the cost of complying with the new regulations would rise from about $5,000 to about $220,000.
Related
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.
Share