Malaysian regulators extend moratorium to summer 2018 for qualifying medical device registrants

Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed. Get the full story here at the Emergo Group’s blog. The

Medical Device Excise Tax set to return early this year

By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

FDA refines least burdensome guidance for medical device oversight

Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. 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

Upcoming changes to FDA electronic medical device reporting in 2018

Registrar Corp. Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury.  An adverse event is when a device has a malfunction that could cause death or serious injury.  Importers report this information to the manufacturer.  The FDA has announced

Do not let the spreadsheet be the database – centralize it

Charlotte Morello, Novasyte Health It is easy to fall into the rhythm of receiving multiple spreadsheets from various sources – be it sales, regulatory, marketing or quality – and by having them in one place, feeling like the recall is “under control.” In working with more than half of the largest med-tech companies globally, Novasyte

Develop a methodical approach for the field strategy

Charlotte Morella, Novasyte Health Prior to launching a field team to address the product need, it is critically important to assess the effectiveness of the field strategy as it could result in a significant, potentially unnecessary, budgetary hit. 1. What is the goal? Start by understanding and having internal alignment on the target metrics and/or

How to maintain accurate consignee recall data

Charlotte Morello, Novasyte Health This is never as simple as it sounds, and it may even sound obvious. That said, it is one of the critically important steps to ensuring a recall is executed accurately and timely. At the end of the day, bad data costs money. It costs to acquire, compile, store and (mis)manage/maintain. It

Recall case study: Achieving FDA compliance in an average of 10 weeks

Charlotte Morello, Novasyte Health A global healthcare organization had multiple nationwide recalls with over 1.8 million units in 2,500 facilities. Facing internal bandwidth constraints, Novasyte was hired as the partner-of-choice to manage the recall execution. Goals The customer’s goal was to complete the following tasks as quickly as possible. Notifications: 100% notification attempts, as per

What is the current recall landscape in the medtech industry?

Charlotte Morello, Novasyte Health Product recalls happen. Even to the most diligent organizations. With the medical device landscape continuously evolving, organizations must be agile and ready to respond to a recall at any moment. In looking at the annual number of medical device recalls in the graph below, one thing is known – recalls are

European Union IoT cybersecurity recommendations for medical devices

By Stewart Eisenhart, Emergo Group A new set of critical infrastructure security recommendations from European regulators targets the Internet of Things (IoT), with significant implications for medical device manufacturers and health technology developers’ cybersecurity risk mitigation efforts ahead of a major data protection compliance deadline in 2018. Get the full story here at the Emergo

Effective design considerations for medical device warning labels

By Michael Wiklund, Emergo Group Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies

By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

Overmolding: 2 types to know

MTD Micromolding Some micro projects require specialty micro injection molding processes, such as overmolding. Overmolding involves two or more materials molded together to become one part. Examples include molding plastic over plastic or molding plastic over a preformed part, such as a metal insert. (See examples of common polymers and substrates below.) MTD specializes in

FDA publishes final guidance for UDI direct marking requirements

David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. The

New harmonized standards for medical devices, IVD in Europe

By Stewart Eisenhart, Emergo Group The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU). 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