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FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review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SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.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The draft guidance clarifies the kinds of changes that trigger the need for a new submission, such as specific kinds of labeling changes, changes to the technology used in the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This draft guidance is one of 25 action items listed in FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability,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510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change in an Existing Device, Draft Guidance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 Technologyâ„¢ 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:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
(Date:6/24/2016)... San Francisco, CA (PRWEB) , ... June 24, ... ... at CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has ... , self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):