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Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.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:10/12/2017)... , Oct. 12, 2017 AVACEN Medical , ... company with their  2017 New Product Innovation Award for ... extensive primary and secondary medical device market research by Frost ... its first-to-market OTC, drug-free pain relief product, the AVACEN 100, ... to treating fibromyalgia widespread pain. ...
(Date:10/12/2017)... -- West Pharmaceutical Services, Inc. (NYSE: WST), ... administration, today announced that it will release third-quarter 2017 ... 26, 2017, and will follow with a conference call ... a.m. Eastern Time. To participate on the call, please ... is 94093362. A ...
(Date:10/11/2017)... 11, 2017  Caris Life Sciences ® , a ... promise of precision medicine, today announced that St. Jude ... Oncology Alliance™ (POA) as its 17 th member. ... Jude Crosson Cancer Institute will help develop standards of ... tumor profiling, making cancer treatment more precise and effective. ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... to meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s ... experts and tested to meet the highest standard. , These products are ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... The American ... Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium ... 8. , In honor of Morris F. Collen, a pioneer in the field of ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare ... Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during ... , The annual award competition recognizes editorial and design excellence across a range of ...
Breaking Medicine News(10 mins):