FDA clarifies if microneedling should be classified as a medical device

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

South Korean regulators change new medical device regulations

By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Russian regulators changing medical device, IVD regulations

By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in

FDA plans to launch Premarket Approval pilot program for high-risk medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

FDA user fees for medical device companies to rise 33%

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting Oct. 1. 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

FDA, Brazil ANVISA update MDSAP medical device QMS audit organizations lists

By Stewart Eisenhart, Emergo Group Regulators in the US and Brazil have updated their lists of organizations approved to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). 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

FDA clarifies Early Feasibility Study program for innovative medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

What FDA medical device user fee reauthorization means for registrants

By Stewart Eisenhart, Emergo Group After two years of negotiations, the U.S. government has enacted the FDA Reauthorization Act of 2017, or FDARA, that enables the agency to continue using medical device, drug and other health product user fees as a key source of funding through 2022. Get the full story here at the Emergo

FDA adds UL2900 standard for medical device cybersecurity

By Stewart Eisenhart, Emergo Group US medical device regulators have officially included a new cybersecurity standard from UL to their list of recognized standards for use in premarket reviews. 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

How FDARA is making a difference for industry and patients

Drs. Peter Marks, Jeffrey Shuren, and Janet Woodcock, FDA For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product

FDA pre-certification for software program: key questions and eligibility requirements

Stewart Eisenhart, Emergo Group Following the rollout of a pre-certification pilot program for digital health technology and software developers, the U.S. Food and Drug Administration has identified and answered several frequently asked questions regarding participation. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

China joins ICH in pursuit of global harmonization of drug development standards

Theresa M. Mullin, FDA Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination. I am pleased to have been in China recently, when the China Food and Drug Administration

FDA unveils digital health technology changes

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products. Get the full story here at the Emergo Group’s blog. The

Chinese regulators answer two common clinical trial questions

By Stewart Eisenhart, Emergo Group China Food and Drug Administration (CFDA) regulators have addressed frequently asked questions regarding clinical trial requirements for medical devices. 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 of MedicalDesignandOutsourcing.com or its

Using robot assistance in neurosurgery for faster seizure mapping

Head shaved, a little boy rests on the operating table, deep under anesthesia. His parents have brought him to Boston Children’s Hospital in hopes of determining the cause of his seizures. Now, neurosurgeons Scellig Stone, MD, PhD, Joseph Madsen, MD, and their colleagues in the Epilepsy Center are performing a procedure designed to monitor seizure