News | Cardiovascular Business | April 25, 2018

FDA Announces New Medical Device Safety Action Plan

Document outlines the agency’s plan to encourage device innovation while protecting patient safety and informing patients and providers

FDA Announces New Medical Device Safety Action Plan

April 25, 2018 — The U.S. Food and Drug Administration (FDA) released a new Medical Device Safety Action Plan outlining how the agency will encourage medical device innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed.  

“All medical devices have benefits and risks. And some of these risks are better understood once the device is more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians,” said FDA Commissioner Scott Gottlieb, M.D. “Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings.”

In the plan, subtitled “Protecting Patients, Promoting Public Health,” the FDA describes key actions it will take in the following areas:

  • Establish a robust medical device patient safety net in the United States;
  • Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations;
  • Spur innovation towards safer medical devices;
  • Advance medical device cybersecurity; and
  • Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.

The FDA welcomes comments and feedback on this proposal and encourages other ideas and suggestions on how it can strengthen its regulatory programs. Input may be submitted through the public docket (FDA-2018-N-1315) at www.regulations.gov.

For more information: www.fda.gov

 

Related Content

Researchers raised the question whether an economic benefit should be assessed in FDA reviews. A large amount of the bill for atrial fibrillation catheter ablation procedures is the cost of the mapping and ablation catheters.

A large amount of the bill for atrial fibrillation catheter ablation procedures is the cost of the mapping and ablation catheters. Researchers raised the question whether an economic benefit should be assessed in FDA reviews. 

Feature | Cardiovascular Business | January 14, 2019 | Philip Jacobs, DPhil, Ilke Akpinar, M.D., Thanh Nguyen, M.D., Ph.D., Rupinder Sandhu, M.D., and Lars Thording Ph.D.
In an age when everything in medicine is now looked at though a cost vs. benefit analysis and U.S.
GE Submits Initial Public Offering Paperwork for Healthcare Division
News | Cardiovascular Business | December 19, 2018
As part of its plans to spin off its healthcare division into a separate company, GE reportedly submitted the paperwork...
Affordable Care Act Ruled Unconstitutional in Texas Federal Court
News | Cardiovascular Business | December 17, 2018
A judge of the Federal District Court for the Northern District of Texas ruled the Affordable Care Act (ACA)...
Average Age of U.S. Cardiologists Up While Income is Down
News | Cardiovascular Business | October 25, 2018
Overall cardiology compensation has dropped for the first time since 2014, according to the sixth annual Cardiovascular...
American Heart Association and The Joint Commission Merge Cardiac Certification Programs
News | Cardiovascular Business | October 15, 2018
The nation’s two leading cardiac accreditation and certification organizations are joining forces to offer a single...
ZHealth Launches Etch Cardiovascular Coding Software
Technology | Cardiovascular Business | October 10, 2018
October 10, 2018 — Medical coding software provider ZHealth recently unveiled Etch, the first-ever software platform
A hands-on-training session at TCT 2018 that instructed interventional cardiologists how to use an intra-cardiac echo (ICE) catheter to image the chambers inside the heart with a catheter based ultrasound imaging system.  The training area was sponsored by Siemens Healthineers

A Siemens-sponsored hands-on-training session at TCT 2018 that instructed interventional cardiologists how to use an intra-cardiac echo (ICE) catheter to image the chambers inside the heart with a catheter based ultrasound imaging system.  Regular training is needed to build customer satisfaction, especially in light of regular staff turnover.

Feature | Cardiovascular Business | October 10, 2018 | John Larson
Years ago, I owned a computer that ran a spreadsheet program called Lotus 1-2-3.
GlobalData: Amazon Poised to Make Huge Strides in Healthcare
News | Cardiovascular Business | August 31, 2018
A new report from data and analytics company GlobalData suggests that Amazon is poised to make huge strides in...
CMS Proposes Overhaul of Medicare's Accountable Care Organization Program
News | Cardiovascular Business | August 09, 2018
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule August 9 that would overhaul the Medicare...
ECRI Institute Announces New Clinical Guideline Repository Website
News | Cardiovascular Business | July 27, 2018
July 27, 2018 — Following the deactivation of the National Guideline Clearinghouse (NGC) by the Agency for Healthcare
Overlay Init