Regulation – Enzyme

Artificial Intelligence Medical Devices SaMDOctober 15, 2024

Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech

By Shawn M. Schmitt Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster – and believes it’s a win-win for manufacturers and...

Medical DevicesJuly 18, 2023

Traceability Analysis Critical to Successful Medical Device Development

If a traceability analysis isn't performed correctly or at the right time or frequency, gaps may go unnoticed that could negatively impact patient safety, device effectiveness, overall patient experience, regulatory submissions, and even result in a recall once the device is commercialized.

Artificial Intelligence Clinical Decision Support SaMD SiMDJune 15, 2023

What Caption Health’s FDA Approval Reveals About Successful PCCPs

The FDA’s draft guidance for predetermined change control plans (PCCPs) is months away from conversion into a final guidance, but that hasn’t stopped software developers from creating products with a PCCP component for the U.S. market. The FDA approved the de novo application by Caption Health on Feb. 24, 2023, for a machine learning (ML) product that processes ultrasound images to calculate left ventricular ejection fraction (LVEF).

Artificial Intelligence Digital Health PharmaJune 6, 2023

FDA Releases Discussion Paper for AI in Drug Development

This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.

Artificial Intelligence Digital Health PharmaApril 5, 2023

FDA Takes Next Step Toward Digital Health in Drug Development

The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.

Clinical Decision Support Laboratory-Developed Tests Medical DevicesMarch 28, 2023

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

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).

Augmented/Virtual RealityFebruary 15, 2023

Data, Standards Emerging for AR/VR Product Development

Augmented reality and virtual reality (AR/VR) might never dominate the world of medical technology the way cardiology devices once had, but AR/VR products are becoming more important as digital health and telehealth play an increasingly central role in 21st Century healthcare.

Biotech PharmaFebruary 2, 2023

FDA Guidance Documents are Vital in De-Risking REMS

The FDA’s risk evaluation and mitigation strategy (REMS) requirements are among the most demanding of a pharmaceutical or biotech manufacturer’s postmarket requirements, and it is important to plan adequately for these programs, given the cost of a failed first attempt.

Medical DevicesJanuary 24, 2023

Human Factors Engineering a Demanding but Vital Requirement

A recent FDA guidance on human factors engineering (HFE) provides some crucial insights into the agency’s expectations for premarket submissions, but appropriate planning in the early stages of product development can go a long way toward making HFE an asset in development of products.

Medical DevicesJanuary 17, 2023

Extension of MDR Transition Proposed by European Commission

The European Commission (EC) has proposed to extend the transition period for medical devices under the Medical Device Regulation (MDR), a proposal which must go through several more steps before full legal adoption.

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