February 17, 2022

Federal Court Rules that Some Imaging Agents Must be Classified as Medical Devices, Not Drugs

In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs.

Recently, the FDA lost its bid in federal court to retain the discretion to classify some imaging agents as drugs, even when they meet the definition of a device. This ruling has provoked continuing objections from both pharma and medical device industry players, as companies would be faced with the challenges to switch from drug good manufacturing practices (GMPs) to the quality systems regulations that apply to medical devices.

What do you think? Join the conversation online.


Criterion Edge Can Support Your Transition to Compliance

Reach out to Criterion Edge for support to get your technical documents of existing devices ready for MDR transition. Or get your new devices MDR compliant. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.

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September 28, 2021

[FEATURED] QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo

For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame Ulmer and Josh Levin to answer six questions about the upcoming draft harmonized Quality System Regulation from the US FDA.

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December 7, 2020

Risk Benefit Analysis and Residual Risk are Key Components of ISO 14971:2019

Author: Nupur Srivastava, PhD  | December 7, 2020

The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is not only safe but also provides a medical benefit. The reference to benefit is included throughout the standard, and the definition for “benefit” is included for the first time.  

ISO 14971:2019 Definition of Benefit: a positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health. 

As outlined in the standard, risk has two key components:  

  • The probability of occurrence of harm; and 
  • The consequences of that harm, that is, how severe it might be. 

The newest ISO 14971:2019 standards emphasize that manufacturers need to demonstrate that the benefits outweigh the risks, as well as mitigating risks. Clause 7.4 of ISO 14971:2019 has even been retitled “Risk/Benefit Analysis” to align with regulatory changes.   

Examples “benefits” provided ISO 14971:2019: 

  • Positive impact on clinical outcome 
  • Patient’s quality of life 
  • Outcomes related to diagnosis 
  • Positive impact from diagnostic devices on clinical outcomes 
  • Positive impact on public health 
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November 18, 2020

Medical Device Manufacturers Transitioning to ISO 14971:2019 Need to Perform a Gap Analysis and Create a Cross-Functional Risk Management Team

Author: Nupur Srivastava, PhD  | November 18, 2020

There has been a lot of discussion on the updated International Organization for Standardization (ISO) 14971:2019,  and experts agree that medical device manufacturers need to perform a gap analysis and create a cross-functional team to meet these risk management requirements.  

Risk management plays a critical role in getting medical devices into the market, and ISO 14971:2019 “was designed to better align with medical device regulations around the world.” The global regulatory landscape has been very dynamic around the areas of risk management, as well as safety and performance. 

Tips on Putting Risk Management into Quality Systems During the Transition to ISO 14971:2019 

Two experts shared insights during an interview with Medtech Insight. Jos Van Vroonhoven, convener of ISO Technical Committee 210, Joint Working Group 1 (TC210/JWG1) and a senior manager for standardization for device giant Philips Healthcare, and Don Powers, a member of ISO TC210/JWG1 and long-time industry expert, said that the third edition of ISO 14971 provides more precise guidance and greater detail in the application of risk management concepts.  

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