Navigation Links
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
Date:8/15/2011

SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

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

Released today, the guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.

In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer's ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.

Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.

Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.

"Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices. This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision."  

The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA's decision making process even more transparent.

For more information:

Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm267829.htm

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.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.

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 New Policy for Some Diagnostic and Radiology Devices
2. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
3. Mangrove Partners Proposes Fully-Financed Dividend Recapitalization to Board of CPEX Pharmaceuticals, Inc.
4. FDA Proposes Withdrawal of Low Blood Pressure Drug
5. American Association for Homecare Proposes Strong Anti-Fraud Measures in Medicare, Applauds HHS Testimony Today That Pledges to "Stop Fraud Before it Starts"
6. ActivBiotics Proposes Development Strategy for Its Novel Rifamycin Antibiotics
7. Cancer Cure Coalition Proposes Major Changes at the FDA
8. China Medical Technologies Announces the First Inclusion of FISH Tests for Diagnosis of Certain Hematological Malignancies in the Clinical Guidelines Issued by the MOH
9. Global GMP Guidelines Available in Online GMP Library
10. Using Guidelines to Reduce Risk and Ensure Effectiveness in Competitive Intelligence Groups
11. Guidelines for Ventilator Use Help Premature Infants Breathe Easier
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/6/2016)... , Dec. 6, 2016 Two new ... personnel in a simulated mass casualty event Tuesday at ... . The technology debuted before an audience including ... and representatives from Homeland Security, Federal Law Enforcement Agencies, ... Project, known as HiRO (Health Integrated Rescue Operations), was ...
(Date:12/6/2016)... JOLLA, Calif. , Dec. 6, 2016 /PRNewswire/ ... a biopharmaceutical company leading the discovery and development ... new drug development candidates at its R&D day, ... The first candidate, RGLS5040, is an anti-miR targeting ... The second candidate, RGLS4326, is an anti-miR targeting ...
(Date:12/6/2016)... , Dec. 6, 2016  BioAtla, ... the development of Conditionally Active Biologic (CAB) ... Beijing Sinobioway Group Company, Limited (Sinobioway) selected ... development.  The specific program candidates and the ... 2015, BioAtla and Sinobioway entered into a ...
Breaking Medicine Technology:
(Date:12/6/2016)... ... ... Mount Sinai Health System today announced the creation of the Medical Modeling ... order 3D models for their cases. Virtual reality, simulation, and 3D printing services ... resource will be the first of its kind catering to the unique patient-specific modeling ...
(Date:12/6/2016)... ... December 06, 2016 , ... The Touchpoint Solution’s new neuroscience wearable, ... Almost 200 backers pledged more than $25,000 on Kickstarter to bring ... Dr. Amy Serin, an Arizona Neuropsychologist and inventor, says she feels like she stumbled ...
(Date:12/6/2016)... ... 06, 2016 , ... After 30 years with The Hearing ... announced her retirement from HASA at the end of 2016. ... individuals and families with hearing and speech services. She has overseen the establishment ...
(Date:12/6/2016)... ... ... It can be argued that people these days spend as much time searching ... their human friends and family. As pets have assumed a bigger role in ... pet products has also increased. , For this reason, America’s Pet Health ...
(Date:12/6/2016)... Atlanta, GA (PRWEB) , ... December 06, 2016 ... ... innovation and the impact of new federal healthcare regulations at the 7th annual ... Galleria Centre, Atlanta. , Andy Slavitt, acting administrator for the Centers for Medicare ...
Breaking Medicine News(10 mins):