Navigation Links
FDA Seeks Comment on Streamlined Review of Lower Risk, New Technology, Devices
Date:9/30/2011

SILVER SPRING, Md., Sept. 30, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet the requirements for clearance under the better-known 510(k) review process.

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

Before manufacturers may market most low to moderate-risk medical devices, such as certain catheters or diagnostic imaging devices, they must obtain FDA "clearance" of a premarket notification or 510(k), named after the section of federal law that describes this notification requirement. Generally, 510(k) submissions must demonstrate that the new device is substantially equivalent to another, legally marketed medical device that is also low to moderate-risk.

However, some low to moderate-risk medical devices are novel and not comparable to an already legally marketed device. Legislation passed by Congress in 1997 created the de novo process for these types of devices.

Currently, devices are only considered for the de novo program after the agency rejects a 510(k), establishing that the device is not substantially equivalent to another legally marketed device.

Although FDA has reviewed and granted a number of de novo petitions since the 1997 legislation, the program has been under-utilized because of process inefficiencies.

The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements, trimming up to 90 days from the process and fostering more efficient, early interaction between manufacturers and the FDA. It also provides clarity for manufacturers on the suitability of a device for the de novo process.

"Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients."

This draft guidance is one of 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched earlier this year to improve the predictability, consistency and transparency of the agency's pre-market review programs.  

For more information:

Draft Guidance for Industry and Food and Drug Administration Staff: De Novo Classification Process (Evaluation of Automatic Class III Designation)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm

Examples of recent de novo devices:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm232269.htm

FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.htm

CDRH Plan of Action for 510(k) and Science
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.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: Karen Riley, 301-796-4674, karen.riley@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. CSL Behring Seeks Proposals for Interlaken Leadership Awards, Supporting Innovative Research Into Neuroimmunology
2. FDA Seeks Comment on Proposed Guidelines for High-Quality Clinical Studies
3. Seymour Hospital Seeks to Meet Meaningful Use Requirements With Prognosis ChartAccess® Comprehensive EHR
4. Warner Chilcott Seeks to Refinance its Existing Credit Agreement
5. FDA Seeks to Invest in Foodborne Illness Prevention, Medical Product Safety and Countermeasures
6. The Welcome Back Awards Seeks Nominations to Honor Leaders in the Depression Community
7. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
8. Study Seeks Volunteers to Measure Safety of Treatment Boost for Patients with Oropharyngeal Cancer
9. Abbott Seeks FDA Approval of a New Six-Month 45-mg Formulation of Lupron(R) Depot for the Palliative Treatment of Advanced Prostate Cancer
10. We Keep Moving Project Seeks Stories of People Across the Country Living With and Affected by MS
11. Sigma-Aldrich Announces SAGE(TM) Priority Partners Program; Seeks Researchers to Evaluate New Knockout Rat Models
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... , Jan. 20, 2017  Ethicon ... acquired Megadyne Medical Products, Inc., a privately ... and markets electrosurgical tools used in operating ... intelligence of Ethicon,s* advanced energy devices with ... a major step forward in Ethicon,s goal ...
(Date:1/20/2017)... DUBAI , VAE, January 20, 2017 ... den stark gestiegenen Bedarf an Nothilfe   Die ... um Platz für Hilfsgüter zu schaffen   ... Vizepräsident und Premierminister der VAE sowie Herrscher von ... Umfang der internationalen Stadt der Hilfe (International Humanitarian City ...
(Date:1/19/2017)... -- The Global Therapy Partnering Terms and Agreements since ... and agreements entered into by the world,s leading healthcare ... deals by value - Deals listed by company A-Z, ... report provides understanding and access to the partnering deals ... companies. The report provides an analysis of partnering ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... ... Forgive You”: a fine examination of how God handles sin, including how to let ... Stephen Miller, who, for over ten long years has been waiting to release this powerful ... Tobago, he has been serving the Lord for over twenty years, and he has been ...
(Date:1/20/2017)... ... ... to Christmas:” a beautiful and enchanting tale that teaches children the true meaning of Christmas. ... in Oklahoma City, and a devoted woman of faith. , “Becoming a parent changes ... back of my mind for years, but actually doing it might have been a while ...
(Date:1/20/2017)... ... January 20, 2017 , ... “God's Miracle Man: Against ... Odds” is the creation of published author, Keith C. A. Tucker, son of Minister ... Fellowship World Outreach pastured by Reverend Mark Hardy , “While sitting up in bed, ...
(Date:1/19/2017)... ... January 19, 2017 , ... Next week after January 20th, the fear for ... games that circumvent health needs of over 30 million. Many interviews with Dr. Carol ... needs government public servants were suppose to prioritize. Interviews provided below. , ...
(Date:1/19/2017)... Florida (PRWEB) , ... January 19, 2017 , ... This ... LCSW, announced that the name of their drug rehab center in Delray Beach, Florida ... we recognize that not only stars such as Philip Seymour Hoffman and Chris Farley ...
Breaking Medicine News(10 mins):