By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has issued new draft guidance clarifying the agency’s Pre-Request for Designation (Pre-RFD) process whereby combination product manufacturers may request initial feedback regarding classification and regulatory oversight questions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Does your medical device and IVD sales need an import license in India?
By Stewart Eisenhart, Emergo Group India’s medical device registration system is still transitioning to a more formalized and predictable framework, which has raised questions from foreign manufacturers about what regulators do and do not currently require for market authorization in the country. In many cases, one requirement foreign firms can be sure of is the […]
FDA delays final guidance plans for laboratory developed tests
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have put on hold plans to publish final guidance regarding laboratory developed tests (LDTs) in order to develop a more appropriate oversight approach, according to the agency. The opinions expressed in this blog post are the author’s only and do […]
Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Center of Excellence launch
Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. The FDA is taking important steps to formalize […]
Medical device industry laws in the wake of “Hard Brexit”
By Ronald Boumans, Emergo Group In 2016, we discussed the possible options for what a Brexit could look like and what the British prime minister meant with “Brexit means Brexit.” The official date of announcing formally that the United Kingdom wants to leave the European Union is fast approaching. Get the full story here at […]
FDA Advisory Committees: Independent, Informed, Essential, and Evolving
By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. Just as importantly, they offer a forum […]
Introducing IMEDS, a public-private resource for evidence generation
By: Robert M. Califf, M.D. FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. These evaluations include epidemiologic studies of medical […]
South Korean medical device regulatory changes updates
By Stewart Eisenhart, Emergo Group Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Selecting seals for new insulin delivery devices
High technical precision in insulin pump seals is important for ensuring that seals meet regulatory requirements and will be operationally sound. Drew Rogers, global director of healthcare & medical, Trelleborg Sealing Solutions With more than 400 million adults worldwide suffering from diabetes and 1.5 million deaths directly attributed to the disease each year, it’s no wonder […]
