Category: Medical Devices

Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to...
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Medical Device User Fees (MDUFA)

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees...
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FDA Recognized Consensus Standards

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA...
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Digital Health Unit

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital...
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Transitioning to ISO13485:206

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach. This doesn’t mean that the traditional process approach has gone away, it...
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The NEW ISO 13485:2016 – Procrastination Can Cost You

ISO 13485 is the international standard medical device companies follow to demonstrate their ability to consistently meet both customer and regulatory requirements with their devices and related services. Regulators worldwide, including the EU, Canada, Australia and Japan, have integrated ISO 13485 into their regulatory requirements. The standard is designed to be used by organizations throughout...
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