The FDA is hosting a webinar on February 2 for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.
The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance, regulatory documents, communications and other public documents.
As data, rather than document-based dossiers, become the focus for regulatory processes, regulatory affairs managers need to consider whether team skill sets need to be refreshed to reflect new ways of working.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
The industry struggles with various unknowns that impact efficiency, quality, and as a result, finances. This article reviews some of these challenges and how to overcome them.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
There really is no excuse for receiving a Form 483 observation for management review.
According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
