Documents
IVDR: What You Need to Know about Europe’s Changing IVD Market
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...
FDA Cracking Down on Poor Performing EUA Tests
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...
The Final Guidance: FDA on Multiple Function Device Products
On July 28th, the FDA issued the final guidance pertaining to multiple function device products (MFDPs). Products may include several functions and the FDA is now in the process of accommodating for such devices, which can get complicated. MFDPs are products with one...
Harmonization of the Quality System Regulation
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...
FDA Restarting Domestic Inspections
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...
Electronic Submissions For Medical Devices
On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as the FDA’s plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA). The FDA has stated that additional details will be laid out in...
FDA Publishes “Review and Update of Device Establishment Inspection Processes and Standards” Guidance
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...
Pre-Sub Process Recommendations
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...
New and Important Distributor Requirements Under EU MDR
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...
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
In October 2019, FDA released a guidance suggesting new labeling and performance testing relative to 510(k) premarket notification submissions for coronary, peripheral, and neurovascular guidewires under the product codes DQX and MOF. According to FDA, these new...
