"WA 0" - Enzyme

MDCG Provides Roadmap for MDR Device Transition

May 25, 2023

An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market.

Company News

Dr. Michelle Rubin-Onur Joins Enzyme as Director of Regulatory

May 25, 2023

Michelle will review submissions for Enzyme clients and consult with them on regulatory strategy as well as provide valuable input on Enzyme’s product roadmap. She has authored and led numerous premarket submissions and regulatory strategies for Class I-III devices.

Medical Devices SaMD

IMDRF Legacy Device Cybersecurity Guidance Highlights Need for Proactivity

May 10, 2023

One of the essential elements of this guidance is that the end-of-life/end-of-service (EOL/EOS) declaration for a software or firmware component can precipitate the same state for the medical device manufacturer’s (MDM’s) product, a problem that must be dealt with in advance to ensure that the MDM is not forced to prematurely withdraw its medical device.

Digital Health Medical Devices SaMD

Digital Tools Ease the Burden of Clinical Trial Monitoring

April 27, 2023

Clinical trial monitoring for FDA-regulated products can be expensive and troublesome, but digital health technologies (DHTs) can make the process less painful and more cost-efficient. However, in order for clinical trial sponsors to enjoy these benefits, proper planning and execution will be necessary, according to a new FDA guidance for clinical trial monitoring.

Medical Devices

FDA’s Refuse-to-Accept Guidance for Cybersecurity Raises the Stakes

April 20, 2023

This short, 6-page guidance casts a long shadow across the medical device landscape. The guidance states that the agency will reject an application that fails to provide adequate cybersecurity measures in premarket applications — just one of several recent developments that show just how serious the U.S. federal government is about cybersecurity.

Artificial Intelligence SaMD

FDA (Finally) Publishes Change Control Draft Guidance for Artificial Intelligence

April 12, 2023

Several features of this draft suggest companies will have to do a significant amount of work in the premarket phase for development of a predetermined change control protocol (PCCP), making the development process potentially lengthier and more expensive.

Clinical Decision Support Laboratory-Developed Tests Medical Devices

Editorial: Pen-and-Phone Approach to Regulation Endangers FDA’s Legitimacy

March 28, 2023

There is a growing — and disconcerting — trend in which FDA resorts to regulation and lawmaking by fiat, overstepping the authority granted to it by Congress. Of particular concern are recent actions taken in regard to clinical decision support (CDS) software and laboratory-developed tests (LDTs).

Switch from Greenlight to Enzyme

March 25, 2023

Artificial Intelligence Manufacturing Pharma

FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing

March 21, 2023

The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.

Jacob Graham

March 21, 2023

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