Navigation Links
FDA Proposes New Policy for Some Diagnostic and Radiology Devices
Date:7/7/2011

SILVER SPRING, Md., July 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.

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

The draft guidance lists 30 different device types, including common urine and blood tests, alcohol breath tests, blood clotting protein tests, and radiology device accessories, such as film cassettes, film processors, and digitizers.  FDA intends to exempt these devices from premarket notification requirements through the appropriate regulatory processes.  In the meantime, however, FDA does not intend to enforce the premarket notification requirements with respect to these devices provided that they do not exceed the limitations on exemption specified in the device classification regulations.

FDA intends to continue to enforce all other applicable requirements, including, but not limited to, registration and listing and Good Manufacturing Practices as set forth in the Quality System regulations.

"The safety and effectiveness of these devices have been well demonstrated over the years," said Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "By addressing the risk level of these devices, the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers, while making sure the public has safe and effective devices."

The device types listed in the draft guidance include devices identified by the FDA as those for which less stringent oversight would not compromise public health.

The FDA is seeking further comment on the draft guidance from manufacturing, clinical and patient communities. The draft guidance is open for comment for 90 days.

In the future, the FDA also intends to reduce the pre-market regulatory burden on additional in vitro diagnostic and radiology device types.

For more information:

FDA:  Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm262071.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.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@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. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
2. Mangrove Partners Proposes Fully-Financed Dividend Recapitalization to Board of CPEX Pharmaceuticals, Inc.
3. FDA Proposes Withdrawal of Low Blood Pressure Drug
4. American Association for Homecare Proposes Strong Anti-Fraud Measures in Medicare, Applauds HHS Testimony Today That Pledges to "Stop Fraud Before it Starts"
5. ActivBiotics Proposes Development Strategy for Its Novel Rifamycin Antibiotics
6. Cancer Cure Coalition Proposes Major Changes at the FDA
7. NxStage® Supports Initiative by Patient Advocacy Groups to Educate Policymakers about the Benefits of Frequent Home Hemodialysis
8. Shareholders to Challenge Johnson & Johnsons Support for Left-Wing Policy Agenda: CEO William C. Weldon to Be Questioned on Firms Failure to Disclose Financial Information on Firms ObamaCare Lobbying It Pledged to Release Last Year
9. Online Forum for Accountable Care Organization Developments Launches Today; Squire Sanders Sponsorship Reflects Commitment to Leadership in Emerging Health Policy Debate
10. Despite New Changes, Highmark Policy Still Threatens Patients With Primary Immunodeficiency Diseases
11. New Highmark Policy Threatens Pennsylvania Patients With Primary Immunodeficiency Diseases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/12/2017)... Sept. 12, 2017  ValGenesis Inc., the global ... is pleased to announce the appointment of Dr. ... its Board of Directors and Chairman of Advisory ... life science companies to manage their entire validation ... paper in this process. Furthermore, ValGenesis VLMS enables ...
(Date:9/7/2017)... Calif. , Sept. 7, 2017  For nearly two decades, New ... in the Assisted Reproduction Insurance industry. Today, New Life Agency announces a ... medications. ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ... ...
(Date:9/6/2017)... -- Robert G. Szewc, M.D., is recognized by Continental Who,s ... his contributions to the Medical field.      ... practice of Kidney and Hypertension Specialists, which specializes in ... He has worked in this position since 2002, and ... as expertise in kidneys, hypertension, chronic disease and anemia, ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... September 22, 2017 , ... Egg freezing and embryo freezing ... have a slight statistical advantage for live births, frozen eggs offer many advantages, ... women undergoing medical treatment or who are concerned about the decline of their ...
(Date:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... 38-Year-Old Plastic ... Surgery Center in Naples, Florida is pleased to announce that Plastic Surgeon Kiranjeet Gill ... 40 Under 40 is an annual award that was started in 2003 ...
(Date:9/21/2017)... Los Angeles, CA (PRWEB) , ... September 21, ... ... co-hosting a lunch and learn with Infinity Behavioral Health Services for professionals in ... Know in a Commercial Payer Audit . , Insurance companies and state ...
(Date:9/21/2017)... ... September 21, 2017 , ... Demonstrating a consistent and continued ... have been awarded five-year accreditation status through the Public Health Accreditation Board ... by a PHAB-accredited health department now extend to more than 203 million ...
(Date:9/21/2017)... ... September 21, 2017 , ... Innovatum ... at the Global GS1 Healthcare Conference 2017 in Chicago, IL on October 17-19, ... ensuring label quality and improving patient safety. , Microscan , a ...
Breaking Medicine News(10 mins):