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Archive for the 'FDA Regulatory Updates' Category

Possible exemption of 337 devices from FDA 510k requirements

Posted on March 21st, 2017 · Posted in FDA Regulatory Updates, Medical Device Trends

FDA is considering the following list of devices as exempt from 510k requirements. The agency continues to emphasize that Class II devices exempt from 510(k) requirements must still meet other US regulatory.. read more

safety first

Medical Device Reporting; FDA eSubmission Mandate

Posted on August 31st, 2015 · Posted in FDA Regulatory Updates

The Medical Device Reporting (MDR) regulation explains mandates for manufacturers, importers, and device user facilities to report device-related adverse events and product problems to the FDA.  Details regarding reporting requirements.. read more


Nanotechnology is impacting our food, cosmetics and drugs!

Posted on August 3rd, 2014 · Posted in FDA Regulatory Updates

Did you know? Over 9,000 personal care and cosmetic products sold in the US contain nano-scale ingredients or ingredients that may contain a nano-scale fraction. This means, those sunscreens, face.. read more


Unique Device Identification (UDI): Which Medical Devices Will Require the Mark and When?

Posted on May 7th, 2014 · Posted in FDA Regulatory Updates

Consumer products have been using UPC identifier codes for years. This simple measure has greatly improved consumer product safety and supply chain efficiency. Finally, the medical device industry and the.. read more


Making medical implants with animal material. Get ready, changes are on the horizon.

Posted on February 3rd, 2014 · Posted in FDA Regulatory Updates

When the word medical device is spoken, most people think of modern gadgets and body parts made with high end plastics and metals. The thought of sheep, bovine (cow), porcine.. read more

FDA releases final guidance for Unique Device Identifier (UDI)

Posted on February 1st, 2014 · Posted in FDA Regulatory Updates

Direct from the Federal Register: 

“The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule.. read more

easy hard

Our medical device is a low risk, class I product. Now our FDA process will be easy. Uh, oh…Think again!

Posted on November 24th, 2013 · Posted in FDA Regulatory Updates

Just because your medical device is considered “low risk” and “simple” doesn’t mean your regulatory process follows the same path. Did you know, some of the most frequent problems in.. read more