Navigation Links
FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review
Date:7/26/2011

SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

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

The 510(k) process is the most common review path to market for lower-risk medical devices. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that the new or modified product is substantially equivalent to another legally marketed medical device.  

Manufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product's safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.

"We are making the regulatory process for medical devices less challenging by better describing our expectations," said Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money."

The draft guidance clarifies the kinds of changes that trigger the need for a new submission, such as specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacture of the device.  

This draft guidance is one of 25 action items listed in FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability, consistency, and transparency of the FDA's premarket review programs.  

For more information:

510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change in an Existing Device, Draft Guidance

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.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. USPTO Issues Patent for CardioGenics Signal Amplification Technology
2. Endo Pharmaceuticals Issues Voluntary, Nationwide Recall of Two Lots of Endocet® (Oxycodone/Acetaminophen, USP) Tablets, 10 Mg /325 Mg
3. Preliminary Results of a Large Scale Study Show ConvaTec Moldable Technology™ Skin Barriers Help to Prevent and Improve Peristomal Skin Issues in Ostomy Patients
4. Health Information Technology: UC San Diego New Seminar Explores Four Critical Issues
5. FDA Issues Draft Guidance for Early Version of an Artificial Pancreas System
6. Amylin Pharmaceuticals Issues Statement Regarding U.S. District Court Order
7. United Kingdoms National Institute for Health and Clinical Excellence Issues Guidance on Percutaneous Tibial Nerve Stimulation for Faecal Incontinence
8. BD Issues 2010 Sustainability Report
9. MedImmune To Present Eight Abstracts on Projects Regarding Thoracic and Respiratory Issues at the Annual American Thoracic Society International Conference
10. FDA Issues Final Guidance for Liquid OTC Drug Products With Dispensing Devices
11. Dehaier Medical Chairman and CEO Issues Letter to Shareholders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... MINNEAPOLIS , April 20, 2017  Cogentix ... company focused on providing the Urology, Uro/Gyn and ... reported that Ash Keswani has joined the Company ... In this newly created position, Mr. Keswani will ... and CEO. "Our organization is delighted ...
(Date:4/20/2017)... 2017 Research and Markets has ... and Market Prospects: Addressing Production Complexities Through Risk Management ... ... Biosimilar Pipeline and Market Prospects: Overcoming Production Complexities Through ... assessment of the current trends in the global biosimilars ...
(Date:4/20/2017)... 2017  CVS Pharmacy, the retail division of ... store design to enhance the retail customer experience ... products and expanded beauty selections paired with informational ... new offerings. Together with its innovative digital programs, ... customer experience at CVS Pharmacy.  ...
Breaking Medicine Technology:
(Date:4/27/2017)... ... 2017 , ... The Incentive Research Foundation is pleased to ... a groundbreaking analysis of how behavioral economics can be applied to the incentive, ... programs, the report highlights proven behavioral economics approaches and the powerful role emotions ...
(Date:4/27/2017)... ... April 27, 2017 , ... Last night, ... CAREGiverSM of the Year for her extraordinary compassion and lifelong dedication to serve ... American professional caregivers for the prestigious award each year – identifying a CAREGiver ...
(Date:4/27/2017)... Atlanta, GA (PRWEB) , ... April 27, 2017 , ... ... is a tragic spike in water-related accidents and drownings during the summer. While most ... reality is that these situations occur every day. Very few people are taking the ...
(Date:4/26/2017)... ... April 26, 2017 , ... Journal of Oral Implantology ... severe consequences to overall dental health, including complications with speech, eating, and overcompensation of ... implants to replace lost teeth. As the number of tooth replacements increase, it is ...
(Date:4/26/2017)... ... April 26, 2017 , ... Elisabete Miranda, president and ... by Enterprising Women magazine as one of its 2017 Enterprising Women of the ... Winners have demonstrated that they have fast-growth businesses, mentor or actively support other ...
Breaking Medicine News(10 mins):