Navigation Links
FDA to Improve Most Common Review Path for Medical Devices

SILVER SPRING, Md., Jan. 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.


Key actions include:

  • Streamlining the "de novo" review process for certain innovative, lower-risk medical devices,
  • Clarifying when clinical data should be submitted in a premarket submission,  guidance that will increase the efficiency and transparency of the review process,
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

These actions will result in "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH).

Before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission.

These submissions are known as 510(k)s for the section of the Federal Food, Drug, and Cosmetic Act that describes this notification requirement. Generally, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.

In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process -- industry argued that the 510(k) process was unpredictable, inconsistent and opaque, while consumers and health care professionals argued that the review process wasn't robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program.  That review is still underway.

In a transparent effort, CDRH sought public input during both the development and review of the two internal reports. The center held two public meetings in the Washington area and separate "town hall" meetings in Minneapolis, Boston and Los Angeles. The FDA also received 76 written comments to three public dockets from industry members, health care professional organizations, consumer groups, patient groups, third-party payers, venture capital groups, agency staff, trial lawyers, foreign regulatory bodies, law firms, individual members of the public, consulting firms and academic institutions.

The two working groups issued 55 recommendations in August 2010. After reviewing public comment, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training. CDRH also is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision and is planning for a public meeting in April to seek additional feedback on two other recommendations.

Dr. Shuren announced the action plan today in an open letter to the public. "We look forward to implementing these changes in support of our overall mission: improving the health of the American public," he said.

For more information

Media Inquiries: Karen Riley, 301-796-4674,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
2. Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial
3. Experimental Drug Ketasyn(TM) Improves Memory in Age-Associated Memory Impairment Study
4. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
5. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
6. One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function
7. One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function
8. Promising Phase 3 Trial Results Show Novel Biologic Therapy Ustekinumab (CNTO 1275) Significantly Improved Psoriasis
9. Surgeons Find That Laparoscopic Banding Procedure Helps Overweight Adolescents Lose Weight and Improve Health
10. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
11. Boston Scientifics Next-Generation Stent Shows Improved Clinical Outcomes in Complex Lesions
Post Your Comments:
(Date:11/29/2015)... -- National Decision Support Company (NDSC) continues to experience ... statewide implementations. As a result, ordering providers now ... than 1 million times per month—all from within ... real-time feedback on the most appropriate imaging test ... at over 100 healthcare systems nationally, representing over ...
(Date:11/27/2015)... Une nouvelle approche consistant ... contre le cancer avancé.    --> ... au traitement photodynamique au Bremachlorin contre le cancer ... nouvelle approche consistant à combiner l,immunothérapie au traitement ...    Clinical Cancer Research . ...
(Date:11/27/2015)... 27, 2015 --> ... go online. The potential to save costs, improve treatment ... far from fully exploited as yet. Here, particular emphasis ... either via mobile tablet or directly at the patients, ... ) -->      (Photo: ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 27, 2015 , ... Lizzie’s Lice Pickers just announced a special promotion that ... of their purchase of lice treatment product. In addition, customers will receive a complimentary ... spokesperson. “Finding lice is a sure way to ruin the holidays, so we encourage ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ProSidebar: ... in Final Cut Pro X. With ProSidebar: Fasion, video editors can easily add ... ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop zones, lines, ...
(Date:11/27/2015)... ... 2015 , ... Consistent with the Radiology Business Management ... Radiology Marketing Programs meeting will showcase some of the best 2015 radiology ... Palace in Las Vegas with a pre-conference session on a collaborative approach for ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... A simply ... Jones, is an interesting show that delves into an array of issues that are ... that could benefit from open dialogue, this show is changing the subjects consumers focus ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... innovative online platform for mental health and wellness consultation, has collaborated with a ... will bridge the knowledge gap experienced by parents and bring advice from parenting ...
Breaking Medicine News(10 mins):