The United Kingdom’s exit from the European Union has had far-reaching ramifications for a wide range of industries, including medical device manufacturing. If you’re a medical device firm selling – or looking to sell – into the UK, significant changes are coming in...
The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this...
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or...
MFDPs are products with one device function and at least one “other function,” which may or may not be considered a medical device.
In May 2018, the FDA first proposed revising its current Quality System Regulation (QSReg) to better align with ISO 13485:2016. The QSReg is the foundation rule for manufacturing safe and effective medical devices to be sold in the US, while ISO 13485 forms the basis...
On July 10, 2020, the U.S. Food and Drug Administration (FDA) stated their plan on restarting onsite domestic inspections. In March, FDA had reduced inspections due to the COVID-19 pandemic, and they have only been conducting mission critical inspections over this...
On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as their plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA).
The FDA has published the final version of a guidance document it initially issued in March 2019 entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The document outlines how the agency plans to implement uniform procedures for...
A Pre-Submission (or Q-Submission) is a structured process for developing interactions between medical device manufacturers and FDA about a myriad of topics that ultimately point to future applications for approval or clearance, prior to the IDE, 510(k), PMA, or De...
European Union (EU) medical device regulations (EU MDR) have significantly increased the requirements for distributors. If you are currently a distributor of medical devices in the EU, or are considering doing so, it is important that you understand these new...