Navigation Links
FDA Proposes Lower Risk Classification, Special Controls for External Pacemakers
Date:10/17/2011

SILVER SPRING, Md., Oct. 17, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

External pacemaker pulse generators are used temporarily to regulate a patient's heartbeat until a permanent pacemaker can be implanted. They are also used following heart surgery or after a heart attack to control irregular heartbeats.  

"The FDA has assessed the benefits and risks of external pacemaker pulse generators," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health (CDRH). "The special controls outlined in this draft guidance, along with general controls, will assure the safety and efficacy of these devices and provide manufacturers with a more predictable path to market."  

General controls include requirements regarding good manufacturing practice, labeling, registering all establishments with the FDA, listing all devices to be marketed and submitting a premarket notification [510(k)] before marketing a device.

However, general controls alone are insufficient to assure safety and effectiveness of Class II devices. In addition to complying with general controls, Class II devices are also subject to special controls, which may include special labeling requirements, mandatory performance standards and postmarket surveillance.

External pacemaker pulse generators are "preamendment" devices, meaning they were on the market prior to the Medical Device Amendments Act of 1976. Approximately 100 preamendment device types were classified as Class III devices, but many continued to be reviewed under the 510(k) program because the FDA did not issue regulations requiring applications for premarket approval (PMAs).

In 2009, CDRH began the process for the review of the remaining Class III preamendment device types subject to 510(k) review to determine whether to reclassify them or require PMAs.  

External pacemaker pulse generators are one of the 22 remaining Class III preamendment devices that have been regulated through the 510(k) premarket submission program, rather than the premarket approval program required for other Class III devices.  

The proposed rule and draft special controls guidance do not significantly change the FDA's review of external pacemakers pulse generators, but they do provide manufacturers with clarity and specific guidance on what information is needed in a 510(k) for these products.

For more information:

Draft Class II Special Controls Guidance Document: External Pacemaker Pulse Generator

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm275701.htm

Proposed Rule: Reclassification of External Pacemaker Pulse Generator Devices

http://www.gpo.gov/fdsys/pkg/FR-2011-10-17/html/2011-26625.htm

515 Program Initiative

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm240310.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
2. FDA Proposes New Policy for Some Diagnostic and Radiology Devices
3. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
4. Mangrove Partners Proposes Fully-Financed Dividend Recapitalization to Board of CPEX Pharmaceuticals, Inc.
5. FDA Proposes Withdrawal of Low Blood Pressure Drug
6. American Association for Homecare Proposes Strong Anti-Fraud Measures in Medicare, Applauds HHS Testimony Today That Pledges to "Stop Fraud Before it Starts"
7. ActivBiotics Proposes Development Strategy for Its Novel Rifamycin Antibiotics
8. Cancer Cure Coalition Proposes Major Changes at the FDA
9. Prescription Drug Manufacturers Underpaid Medicaid Rebates, Federal and State Whistleblower Complaint Alleges
10. FDA Seeks Comment on Streamlined Review of Lower Risk, New Technology, Devices
11. FDA CONSUMER HEALTH INFORMATION - Concentration Lowered in Tamiflu Medication
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2016)... , May 2, 2016  While nearly three-quarters of ... can have on their health, only about half report ... to the results of a new survey announced today ... the start of National Osteoporosis Month, Hologic is raising ... affects nearly 56 million Americans. Osteoporosis is ...
(Date:4/29/2016)... April 29, 2016 ReportsnReports.com ... 2016" market research report that provides an overview ... analysis at various stages, therapeutics assessment by drug ... (RoA) and molecule type, along with latest updates, ... reviews key players involved in the therapeutic development ...
(Date:4/29/2016)... , April 29, 2016 ... life science laboratory due to the growing demands for ... advance technology, contemporary automated systems are already adept of ... by slow, tedious and manual labor. Instrumentation continues to ... not even conceivable just a few years ago. Originally ...
Breaking Medicine Technology:
(Date:5/3/2016)... ... May 03, 2016 , ... ... – a web application that helps people assess their risk of developing Alzheimer’s ... app will provide users a “Risk Reduction Score™” that summarizes how their lifestyle ...
(Date:5/3/2016)... Baltimore, Md. (PRWEB) , ... May 03, 2016 , ... ... devastating consequences of inappropriate or excessive levels of alcohol use. Alcohol and its ... fetal alcohol spectrum disorders to the susceptibility to strokes in those 65 years and ...
(Date:5/3/2016)... ... May 03, 2016 , ... SELEX (systematic evolution of ... a random library of sequences depending on their attraction for a target molecule. ... selection is commonly performed using filters, panning, or affinity chromatography separations. However, these ...
(Date:5/3/2016)... Chicago (PRWEB) , ... May 03, 2016 , ... ... has hired award-winning creative director Joe Ferrazano to serve in the newly created ... Ferrazano will be overseeing the agency’s creative efforts in the Chicago and LA ...
(Date:5/3/2016)... (PRWEB) , ... May 03, 2016 , ... Elizabeth Murray ... pet parrots to join her with one on her shoulder and one on her ... a parking lot because of years of mitral valve prolapse. , The valves of ...
Breaking Medicine News(10 mins):