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SILVER SPRING, Md., Sept. 30, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet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The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements, trimming up to 90 days from the process and fostering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This draft guidance is one of 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched earlier this year to improve the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:5/24/2016)... May 24, 2016 Een app ... zodat zij collectief patiënten kunnen behandelen, hun kennis kunnen ... idee achter de nieuwe en revolutionaire MDLinking App, ontwikkeld ... Nederlandse vaatchirurg dr. Hans Flu en oncologisch chirurg dr. ... inmiddels beschikbaar is, wordt op dinsdag 24 mei officieel ...
(Date:5/23/2016)... May 23, 2016 Global Paclitaxel ... pages, profiles 12 companies and the Paclitaxel analysis in ... on the industry and its players. This ... in nature, details the current state of the industry ... definitions, classifications, applications and industry chain structure. The Paclitaxel ...
(Date:5/23/2016)... , May 23, 2016 Transparency ... " Exocrine Pancreatic Insufficiency Market - Global Industry Analysis, ... ." According to the report, the exocrine pancreatic insufficiency ... 8.3% from 2015 to 2023 to reach US$2.85 Bn ... a condition characterized by the deficiency of the exocrine ...
Breaking Medicine Technology:
(Date:5/25/2016)... FREMONT, CA (PRWEB) , ... May 25, 2016 , ... ... Most Promising Pharma and Life Sciences Tech Solution Providers list of 2016 by CIOReview. ... Most Promising Pharma and Life Sciences Tech Solution Providers 2016 has been concluded with. ...
(Date:5/25/2016)... ... 25, 2016 , ... The World Molecular Imaging Society (WMIS) ... The focus of ADDMI-IG will be geared towards how using molecular imaging can ... ADDMI-IG WMIS will provide a platform for productive discussions about the implementation of ...
(Date:5/25/2016)... ... May 25, 2016 , ... DKT International, ... the developing world, is pleased to release their 2015 global impact data. In ... pregnancies, almost 14,000 maternal deaths and 3.8 million unsafe abortions across 21 countries ...
(Date:5/25/2016)... ... May 25, 2016 , ... Afrimesure specializes in ... and pharmaceutical, to food and HVAC facilities. Their knowledgeable staff also takes care ... For medical applications, Afrimesure offers a variety of MadgeTech systems available for sterilization ...
(Date:5/25/2016)... ... May 25, 2016 , ... Casa Velas, an adults-only boutique hotel ... stones to complement its new wellness suites . The two 1,350 sq. ft. ... plethora of special services and insuite amenities, from a custom soap selection and in-suite ...
Breaking Medicine News(10 mins):