Devices

Predetermined Change Control Plan Principles

FDA, Health Canada, and the UK’s Medicines and Healthcare Products Regulatory Agency have published five guiding principles for predetermined change control plans (PCCPs) for machine learning-enabled medical devices (MLMDs). An FDA post says the principles “draw upon the overarching good machine learning practice guiding principles the three agencies adopted in 2021.

The document says there is international medical device community discussion about the use of PCCPs as a way of managing certain device changes where regulatory authorization before marketing is typically required. It says PCCPs can be used to help:

align regulatory procedures with the rapid and ongoing approach to change management in MLMDs;
manage risks in a timely and ongoing fashion through monitoring, maintenance, and/or improving device performance; and
uphold high regulatory standards to ensure device safety and effectiveness.

For this joint document, it says, a PCCP describes a plan proposed by a medical device manufacturer that specifies:

certain planned modifications to a device;
the protocol for implementing and controlling these modifications; and
the assessment of impact from modifications.

The guiding principles are:

focused or bounded, by limiting proposed changes to modifications within the intended use or intended purpose of the original MLMD;
a risk-based approach that adheres to risk management principles;
evidence-based;
transparent, so that stakeholders stay aware of a device’s performance and use before and after changes are implemented; and
total product lifecycle perspective.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome