Navigation Links
FDAnews Special Subscription Offer for Devices & Diagnostics Letter
Date:8/25/2014

Falls Church, VA (PRWEB) August 25, 2014

Subscribe to Devices & Diagnostics Letter
http://www.fdanews.com/DDLPR

510(k) Guidance Overhauls Agency Risk vs. Benefit Review
For the first time, manufacturers submitting 510(k)s would have to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week.

Manufacturers should be able to demonstrate the likelihood that a risk or beneficial effect will occur and how widely it will occur, the FDA says. For example, a modified device may cause a benefit in only a few patients, or broadly across the patient population, and a specific risk may be rare or common. Those situations would raise different considerations in reviewing a 510(k) submission, the agency adds...

About Devices & Diagnostics Letter
For more than 40 years, Devices & Diagnostics Letter has been a must-read for industry leaders eager to stay in compliance with the FDA.

With 50 issues a year, readers can be confident that they'll stay abreast of the latest FDA regulations because each bi-weekly issue brings the latest regulatory news including:

  •     UDI implementation to cybersecurity
  •     The medical device excise tax
  •     EU device regulations

Plus, each issue is filled with links to draft and final guidances, proposed and final rules, texts of proposed legislation and GAO reports and many others.

Subscribe Today
Order NOW and pay just $947, a savings of $300 of the regular one-year price pf $1,247.

EASY WAYS TO ORDER
Online:     http:// http://www.fdanews.com/DDLPR
By phone: 888-838-5578 or 703-538-7600
Fax:         703-538-7676
Mail to:     FDAnews
                300 N Washington St
                Ste 200
                Falls Church VA USA 22046-3431

100% Money-Back Guarantee. FDAnews' ironclad guarantee ensures satisfaction. If at any time during the one-year subscription the subscriber become dissatisfied, they may cancel and receive a full refund. No questions asked.

ABOUT FDANEWS
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/DDLPR/prweb12116394.htm.


'/>"/>
Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
2. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
3. FDAnews Management Report: Implementing Risk-Based Verification and Validation
4. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
5. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
6. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
7. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
8. FDAnews Announces — New Job Board Now Available on FDAnews.com
9. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
10. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
11. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... Pa. , June 23, 2016 The ... in an outpatient dialysis facility.  Treatments are usually 3 ... 6 hours per visit, including travel time, equipment preparation ... a patient, but especially grueling for patients who are ... of a skilled nursing and rehabilitation centers for some ...
Breaking Medicine Technology: