Navigation Links
FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Date:8/4/2010

Recommendations focus on innovation, regulatory predictability, and patient safety

SILVER SPRING, Md., Aug. 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency's public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

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

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The FDA's Center for Devices and Radiological Health assessment consists of two preliminary reports. One report focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The other evaluates CDRH's use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.

The two documents overlap in several places and cross-reference information. The documents can be found online at

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. China Sky One Medicals Chief Financial Officers Health Issues to Restrict His Availability to Investors
2. ECRI Institute Reissues Cost-Saving Tips to Help Hospitals Make Capital Technology Purchases With Scarce Resources
3. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Issues Practice Guideline Addressing the Management of Gastroesophageal Reflux Disease and Barretts Esophagus
4. FDA Issues Statement on Baxters Recall of Colleague Infusion Pumps
5. ECRI Institute(R) Issues Expanded Recommendations for Controlling CT Radiation Dose: Computed Tomography Dose is on the Institutes 2010 List of Top 10 Technology Hazards
6. Viral Genetics CEO Issues State of the Company Update
7. FDA Issues Complete Response Letter for Low Dose Oral Contraceptive
8. Terumo to Sponsor Presentations on Key Issues in Cardiac and Vascular Surgery at Society of Thoracic Surgeons Annual Meeting
9. FDA Issues Complete Response Letter for Ceftobiprole
10. ECRI Institute Issues Steris System 1 High Priority Alert and Recommendations: Free Guidance to Help Hospitals Map out Transition to Alternative Reprocessing Methods
11. U.S. Patent Office Issues Sword Diagnostics Patent for Highly Sensitive Immunodetection Technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... ORLANDO, Fla. , Aug. 27, 2014 By ... Challenge, you,re likely not living on this planet. The awareness ... social consciousness and has helped to raise over $88.5 Million ... are getting involved and some companies are starting to as ... in Orlando, Florida , who actually works ...
(Date:8/27/2014)... 2014 Pulse Systems, Inc. , an industry-leading ... Management , and Revenue Cycle Management (RCM) solutions , ... by some RCM vendors, at UBM Medica,s Practice Rx ... September 19-20, 2014.  A presenter at the ... with a new session encouraging practices to "Look before You ...
(Date:8/27/2014)... 27, 2014 An experimental drug designed to help ... first treatment for anemia of inflammation, according to results from ... online today in Blood , the Journal ... Anemia is a condition that occurs when red ... properly. When an individual has anemia, the body does not ...
Breaking Medicine Technology:Acorn Stairlifts Gives a Lift to the ALS Ice Bucket Challenge 2Pulse Systems Presents the Truth about Revenue Cycle Management Services at Practice Rx 2Pulse Systems Presents the Truth about Revenue Cycle Management Services at Practice Rx 3Pulse Systems Presents the Truth about Revenue Cycle Management Services at Practice Rx 4Drug Represents First Potential Treatment for Common Anemia 2Drug Represents First Potential Treatment for Common Anemia 3
... Ten percent of cancer patients failed to fill their initial prescriptions ... today in the Journal of Oncology Practice ( JOP ... ). The study was based on an analysis conducted by Avalere ... 2007 to 2009. This study has also been accepted for presentation ...
... The Consumer Healthcare Products Association (CHPA), representing makers ... applauds the U.S. Food and Drug Administration (FDA) ... children the right amount of medicine. Today, the ... Committee recommended enhancing the labels of all OTC ...
Cached Medicine Technology:New Study Finds That 10% of Cancer Patients Abandoned Oral Anti-Cancer Drugs 2New Study Finds That 10% of Cancer Patients Abandoned Oral Anti-Cancer Drugs 3New Study Finds That 10% of Cancer Patients Abandoned Oral Anti-Cancer Drugs 4OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions 2OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions 3
(Date:8/27/2014)... 2014 Many patients believe mental illness ... depression has a mortality rate of about 15%. ... slightly less, though it's offset by an alarming homicide ... order to properly treat and manage symptoms of mental ... be taken as directed. Missed dosages or cutting ...
(Date:8/27/2014)... 27, 2014 Do brands know what consumers ... to shed some light on the topic Sept. 16 when ... the Brand Activation Association and the Association ... hundreds of consumers to learn what types of marketing messages ... influencing a potential buying decision. While the survey focuses on ...
(Date:8/27/2014)... Aspirus Wausau Hospital today announced the first ... Digital O.R. at Aspirus Wausau Hospital, in Wausau, WI. ... rooms will be Buzz, a centralized surgical hub for ... planning, navigation, imaging and communications connectivity. , Buzz ... and hardware all controlled from the full HD 42” ...
(Date:8/27/2014)... Wellesley, Mass., (PRWEB) August 27, 2014 ... report, ADVANCED ORTHOPEDIC TECHNOLOGIES, IMPLANTS AND REGENERATIVE PRODUCTS ... anticipated to increase from $36.4 billion by 2014-end to ... rate (CAGR) of 3% from 2014 to 2019. New ... the major driving forces within the market. , While ...
(Date:8/27/2014)... of the leading purveyors of real and synthetic hair wigs, hair ... its products, for the coming Labor Day. , People searching for ... hair products in two ways: when they spend more than $89 ... LABOR10; while when they spend more than $299, they can save ... code is needed when securely checkout, there are about 50 products ...
Breaking Medicine News(10 mins):Health News:MedicationDiscountCard.com now Makes Brintellix and Mental Illness Medications More Affordable with Discount Cards 2Health News:CRN Set To Release Poll Results On What Marketing Tactics Prompt Consumers To Buy 2Health News:Aspirus Wausau Hospital Announces First Large Scale Digital Operating Room Integration Project in the US 2Health News:Aspirus Wausau Hospital Announces First Large Scale Digital Operating Room Integration Project in the US 3Health News:Global Market for Advanced Orthopedic Technology to Reach $42.2 Billion in 2019; Biotechnological Advancements Driving the Market 2Health News:Global Market for Advanced Orthopedic Technology to Reach $42.2 Billion in 2019; Biotechnological Advancements Driving the Market 3Health News:UniWigs Is Offering A Big Sale for Labor Day on All Its Products 2
... Blue Cross Blue Shield of Michigan announced today that Kevin ... current vice president for products and marketing, will succeed Jeanne ... when Carlson retires at the end of February 2010. , ... and CEO of BCBSM, parent company of Blue Care Network. ...
... - Proposed 30-Year Lease Agreement Will Help Stevens Hospital Expand, ... Wash., Dec. 17 The Board of Commissioners for Public ... for Swedish to lease and assume management of Stevens Hospital ... agreements. The public is invited to a hearing in mid-January ...
... from physician, study finds , THURSDAY, Dec. 17 (HealthDay News) ... parents to place infants on their backs to go to ... SIDS, researchers have found. , Since the U.S. government launched ... infants placed on their backs at sleep time has increased ...
... checkout counters of clothing stores, gas stations -- and adding ... News) -- If you,re hungry while shopping for a new ... sell sweet or salty snacks, a new report finds. , ... far beyond grocery stores to hit most segments of the ...
... ... Fisher Theatre on Dec. 17 for the Detroit-area,premiere of the award-winning musical “Jersey Boys,” Beaumont ... , ... When the cast takes the stage at the Fisher Theatre on Dec. 17 for the ...
... might be more likely to try alcohol, illegal drugs ... believe that smoking cigarettes is riskier than using illicit ... , That perception may increase the likelihood that they,ll ... said. , "We are on the right track with ...
Cached Medicine News:Health News:Stevens Hospital to Affiliate with Swedish 2Health News:Stevens Hospital to Affiliate with Swedish 3Health News:Stevens Hospital to Affiliate with Swedish 4Health News:Doctor's Orders Influence Baby's Sleep Position 2Health News:Wide Array of Stores Now Sell High-Calorie Snacks 2Health News:Jersey Boys' Premiere Benefits Cancer Patients While Launching Beaumont Hospitals Fundraising Campaign 2Health News:Jersey Boys' Premiere Benefits Cancer Patients While Launching Beaumont Hospitals Fundraising Campaign 3Health News:Teens Think Smoking More Dangerous Than Drinking, Drugs 2
... The new line of Myoquick systemplus Multi-channels Evoked ... of Micromed in the neurophysiology field and shows ... Multi-channel EP unit adopt the 32 channels headbox ... of the ISA 100x EP family headboxes: ISA ...
Solid steel construction for lifelong quality. Strong, smooth and quiet electro-mechanical up/down movement. Dual castor, locking wheels for use on carpet or tile flooring. Easy cleaning, deluxe lami...
If you presently have an exam chair that is separate from the instrument stand, we can solve your access problem with a Burton 1200 Chair-exchanger...
... A marvel of engineering and innovative ... precision, unparalleled quality and masterful workmanship. At ... bring the ophthalmic industry a truly innovative ... From product design to quality construction and ...
Medicine Products: