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Blog. Inside the Lines

Possible exemption of 337 devices from FDA 510k requirements

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

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

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3D medical and bio-printing. Get ready, this technology is no longer the future.

Over the last 10 years the 3D printing industry has changed dramatically. As materials and printing technologies have advanced, the shift into printing products for the human body has made.. read more


Nanotechnology is impacting our food, cosmetics and drugs!

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?

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

The most common reasons an FDA warning letter is issued. Are you prepared to avoid these risks?

We can all imagine the pressure associated with receiving an FDA 483 (observations made by FDA during a site inspection) or an FDA Warning letter (violations FDA has documented based.. read more

FDA compliant labels

Do your medical product claims TRULY match the products’ performance?

We all want to use safe and effective medical devices, drugs and cosmetics. How do you properly market your products to assure that necessary medical claims are telling the “whole.. read more


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

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)

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

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Mobile medical apps are changing our health care system; rapidly and drastically.

Did you know, the FDA cleared over 100 medical apps in the last 10 years? 40 of these apps were cleared in just the last 2 years. The medical app.. read more