The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, but what exactly are they and how do you deal with them? To begin it’s important to note that an...
Every medical device manufacturer in the US should expect FDA to conduct an inspection at some point, but what exactly does that entail? As a device manufacturer, you know you are expected to maintain a detailed QMS, implement design controls,...
When most people hear the term “medical device”, they think of surgical and hospital tools, like stethoscopes or surgical staplers. With advancing technology and the population’s increasing interest in staying healthy, the field of at-home medical technology is seeing a...
FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available...
Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? Are you trying to figure out how to navigate the regulatory pathway for marketing your device? Prior to 1997, with the...
The third version of ISO 14971 is currently being published. The new version of ISO 14971 is set for release in Q4 of 2019. Read our blog NEW REVISION OF ISO 14971 COMING SOON. The clause on production and post-production requirements...
The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 days for Traditional 510(k)s!) for certain changes subject to 510(k) submission requirements. FDA released a new guidance document that supersedes the...
ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name suggests, addresses good clinical practices for all pre- and post-market clinical investigations that determine the safety and performance of medical devices. The final...
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological Health (CDRH) is constantly striving towards. Among several other programs introduced or changed over the past couple years, the National Evaluation System for...
With the up-classification of medical devices as per the new EU MDR, software used as a medical device has been affected the most. Under Rule 11: “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes...