Navigation Links
FDA Proposes Lower Risk Classification, Special Controls for External Pacemakers

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).


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 "The special controls outlined in this draft guidance, along with general controls, will assure the safety and efficacy of these devices and provide manufacturers with a more predictable path to market."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

Proposed Rule: Reclassification of External Pacemaker Pulse Generator Devices

515 Program Initiative

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,

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:
(Date:11/25/2015)...  The total global healthcare industry is expected to grow ... Latin America has the highest projected growth at ... Japan ), is second with growth projected at 11.5%. ... healthcare expenditure. In 2013-2014, total government funded healthcare was nearly ... to 41.2% in 2013-2014. In real terms, out of pocket ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma Services ... investment of at least $15.8  Million to expand ... Wilmington, NC . The expansion will provide ... meet the growing demands of the pharmaceutical and ... site expansion will provide up to 40,000 square ...
(Date:11/25/2015)... Israel , November 25, 2015 ... KTOV ) (TASE: KTOV), a biopharmaceutical company focused ... treatment of various clinical conditions, today announced the closing ... American Depository Shares ( ADSs ), each representing 20 ... up to 3,158,900 ADSs. The ADSs and warrants were ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, ... choose to buy during the Black Friday and Cyber Monday massage chair sales ... search the Internet high and low to find the best massage chair deals, they ...
(Date:11/26/2015)... ... November 26, 2015 , ... PRMA Plastic Surgery is updating their ... surgeons performed their 6,000th free flap breast reconstruction surgery! , “What an accomplishment for ... excited to rebuild lives and it’s an honor to have served all of these ...
(Date:11/25/2015)... ... November 25, 2015 , ... Additional breast cancers found with ... according to a study published online in the journal Radiology. Researchers said that ... necessitate a change in treatment. , Breast MRI is the most sensitive technique ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... factory direct sauna parts and accessories. , Sauna accessories help improve the bather ... style and personality. From basic styles for the purist looking for simplicity in ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article published ... and more widely heralded as a breakthrough for performing hernia repairs. The article explains ... laparoscopic surgery is that it can greatly reduce the pain that a patient might ...
Breaking Medicine News(10 mins):