Featured Research

from universities, journals, and other organizations

Many cardiac devices approved by process that often does not require new clinical data

Date:
January 21, 2014
Source:
The JAMA Network Journals
Summary:
Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according to a study.

Many cardiac implantable electronic device models currently in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device, according to a study in the January 22/29 issue of JAMA.

"In the United States, the Food and Drug Administration (FDA) reviews high-risk medical devices -- those that support human life, prevent illness, or present an unreasonable risk -- via the premarket approval (PMA) pathway, through which manufacturers collect preclinical and clinical data as necessary to provide 'reasonable assurance' of the device's safety and effectiveness," according to background information in the article. That process has attracted attention in recent years after recall of device components, like leads from Medtronic Sprint Fidelis and St. Jude Medical Riata implantable cardioverter-defibrillators (ICDs), that were not tested clinically in human trials prior to approval because they were design changes to prior-marketed devices and considered 'supplements' to PMA applications submitted almost a decade earlier.

The process of approval by premarket approval supplement "allow[s] patients to benefit from incremental innovation in device technology by providing efficient and inexpensive FDA review pathways for smaller device changes. Supplements may include major or minor design changes as well as routine changes in labeling, materials, or packaging. By statute, the FDA must seek only the 'least burdensome' supporting data necessary for review."

Benjamin N. Rome, B.A., of Harvard Medical School and Brigham and Women's Hospital, Boston, and colleagues used the FDA's PMA database to review CIEDs (including pacemakers, ICDs, and cardiac resynchronization therapy [CRT] devices) approved as PMA supplements from 1979 through 2012. They identified the number of supplements to each original PMA and characterized the nature of the changes in each supplement.

Seventy-seven approved PMA applications for CIEDs (46 pacemaker devices, 19 ICDs, and 12 CRT devices) were the basis for 5,829 PMA supplement applications, with a median (midpoint) of 50 supplements per original PMA. In the last decade, the number of approved supplements annually increased to 704. Excluding manufacturing changes that do not alter device design, the number of supplements approved each year averaged 2.6 per PMA per year.

Thirty-seven percent of supplements represented at least minor alterations to the device's design or materials. Among 180-day supplements (a type of FDA review process) approved between 2010 and 2012, 23 percent included new clinical data to support safety and effectiveness.

"… Our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness," the authors conclude. However, clinicians and patients should … be aware … that clinical data are rarely collected as part of PMA supplement applications prior to marketing. The recalled Medtronic Sprint Fidelis and St. Jude Riata ICD leads were both PMA supplements -- Fidelis a 180-day supplement and Riata a real-time supplement [a type of FDA review process]. Neither lead was studied in human trials prior to FDA approval. The FDA's approval of many supplements without new human trials, as in the case of these recent ICD changes, highlights the importance of collecting rigorous postapproval performance data," the authors write.


Story Source:

The above story is based on materials provided by The JAMA Network Journals. Note: Materials may be edited for content and length.


Journal Reference:

  1. Benjamin N. Rome, Daniel B. Kramer, Aaron S. Kesselheim. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012. JAMA, 2014; 311 (4): 385 DOI: 10.1001/jama.2013.284986

Cite This Page:

The JAMA Network Journals. "Many cardiac devices approved by process that often does not require new clinical data." ScienceDaily. ScienceDaily, 21 January 2014. <www.sciencedaily.com/releases/2014/01/140121164748.htm>.
The JAMA Network Journals. (2014, January 21). Many cardiac devices approved by process that often does not require new clinical data. ScienceDaily. Retrieved October 21, 2014 from www.sciencedaily.com/releases/2014/01/140121164748.htm
The JAMA Network Journals. "Many cardiac devices approved by process that often does not require new clinical data." ScienceDaily. www.sciencedaily.com/releases/2014/01/140121164748.htm (accessed October 21, 2014).

Share This



More Health & Medicine News

Tuesday, October 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

CDC Revamps Ebola Guidelines After Criticism

CDC Revamps Ebola Guidelines After Criticism

Newsy (Oct. 21, 2014) The Centers for Disease Control and Prevention have issued new protocols for healthcare workers interacting with Ebola patients. Video provided by Newsy
Powered by NewsLook.com
WHO: Ebola Vaccine Trials to Start a in January

WHO: Ebola Vaccine Trials to Start a in January

AP (Oct. 21, 2014) Tens of thousands of doses of experimental Ebola vaccines could be available for "real-world" testing in West Africa as soon as January as long as they are deemed safe in soon to start trials, the World Health Organization said Tuesday. (Oct. 21) Video provided by AP
Powered by NewsLook.com
First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

Newsy (Oct. 21, 2014) A medical team has for the first time given a man the ability to walk again after transplanting cells from his brain onto his severed spinal cord. Video provided by Newsy
Powered by NewsLook.com
CDC Issues New Ebola Guidelines for Health Workers

CDC Issues New Ebola Guidelines for Health Workers

Reuters - US Online Video (Oct. 21, 2014) The U.S. Centers for Disease Control and Prevention has set up new guidelines for health workers taking care of patients infected with Ebola. Linda So reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins