Guidance

A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.

Patient-Reported Outcome (PRO) instruments are the focus of a 26 January final guidance from the US agency. Sponsors can lean on the guidance when selecting, developing or modifying tools for patient data collection.

The goal of the guidance is to make the Case for Quality Voluntary Improvement Program, or CfQ VIP, “more official” at the US FDA, an agency official says. CfQ VIP aims to elevate product, manufacturing and process quality at medical device firms.

The US agency issued a new draft guidance to require medical device and diagnostics manufacturers and distributors to report supply chain issues in the event of a public health emergency.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-eight documents have been posted on the tracker since its last update.

The US agency’s draft document highlights technical considerations to enhance safety and efficacy for the development of medical devices employing physiologic closed-loop control technology. PCLC tech can benefit health care providers by lessening their workloads.

The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for premarket approval. The agency says deficiencies in analytical methods for evaluating CM&S hampers its use in supporting regulatory submissions.

A new guidance document from the US agency strongly urges makers of medical devices for treating benign prostatic hyperplasia (BPH) – a common form of age-related prostate enlargement – to quickly conduct post-treatment evaluations as part of investigational studies.