List is for products that are ‘understood’ and do not present ‘risks’; The FDA released a list of 107 medical devices it will exempt from its 510(k) Premarket Notification Regulations as part of the agency’s efforts to streamline its approval process for products similar to those that have already undergone testing and trials.
Regulatory functions at the U.S. Food and Drug Administration (FDA) were set to undergo a major overhaul in the later months of 2014 after a year-long effort by the Agency recommended making scores of improvements to the way the agency is structured and regulates products.Regulatory functions at the U.S. Food and Drug Administration (FDA) were set to undergo a major overhaul in the later months of 2014 after a year-long effort by the Agency recommended making scores of improvements to the way the agency is structured and regulates products.
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
The Japanese government has set an enforcement date of November 25, 2014 for revised laws that regulate the country’s pharmaceutical and medical device markets.
The Food and Drug Administration issued a new guidance in August 2014 that exempts still more medical devices, some of them consumer devices, from its regulatory scope. This means the manufacturers of these devices, some of which are connected to apps, no longer have to go through the FDA’s 510(k) review process before they bring their product to market.
Cheyenne, WY (KGWN) – Cheyenne Regional Medical Center (CRMC) is one of the first hospitals in the world to use new cutting-edge equipment in its ICU.
The FDA announced July 31, 2014 that it intends to issue a draft guidance soon that would require moderate- and high-risk diagnostics to obtain 510(k) or premarket approval, regardless of their place of origin, putting an end to a battle to regulate laboratory-developed tests (LDTs) that’s been waged for several years. The planned draft guidance on the regulatory oversight of LDTs ,had been held up by the White House Office of Management and Budget since 2010.
Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events? In a new research letter published this week in Clinical Pharmacology & Therapeutics, two FDA researchers argue that “Internet search logs” could be substantially useful to the agency’s drug regulatory staff in determining which drugs might have unforeseen adverse events.
Every type of cancer is unique depending on which cells are affected, how it spreads, and what causes it to arise in the first place. That has been the basic understanding that has marked cancer as an overarching concept for a variety of uniquely different diseases and so each cancer required its own diagnostic mechanism and treatment regimen.
Automatic Test Detects Secondary Cataracts with High Precision