Falls Church, VA (PRWEB) August 25, 2014
Subscribe to Devices & Diagnostics Letter
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of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week.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:
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.
Order NOW and pay just $947, a savings of $300 of the regular one-year price pf $1,247.
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.
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.