Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

FDA Publishes Changes to Premarket Review Standards

Effective March 8, the US FDA has issued modifications to the list of standards used by the agency in its premarket review process for medical devices.

The FDA’s move is intended to help device manufacturers that declare conformity with nationally and internationally developed consensus standards comply with associated requirements, according to the regulator’s Federal Register notice.

Changes to these standards will affect the following medical device product groups:

Anesthesia
Biocompatibility
Cardiovascular
Dental/ENT
General hospital/plastic surgery
IVD
Materials
OB-GYN/gastroenterology
Orthopedics
Physical medicine
Radiology
Software
Sterility

Updated consensus standards will be added to the FDA’s searchable database. Although the new changes have already gone into effect, the agency is accepting comments on an ongoing basis.

Medical device manufacturers whose products fall under any of the 13 categories listed above should familiarize themselves with how the FDA’s modifications may impact premarket reviews of their applications.