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Guidance

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Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

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.

Clinical Trials Guidance Documents

Going PRO: FDA Suggests Best Practices For Choosing, Changing Patient-Reported Outcome Tools

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.

Guidance Documents FDA

FDA Puts Finishing Touches On Draft Guidance To Set Case For Quality VIP Program In Stone

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.

Policy Quality

FDA Wants To Make Permanent COVID-19 Supply Chain Guidance To Prevent Product Shortages

The US agency issued a new draft guidance to require medical device and diagnostics manufacturers and distributors to report supply chain issues in the event of a public health emergency.

Guidance Documents FDA

Global Medtech Guidance Tracker: December 2021

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.

Guidance Documents Regulation

FDA Issues Draft Guidance For Physiologic Closed-Loop Control Devices

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.

FDA Guidance Documents

FDA Offers Framework For Assessing Credibility Of Devices Designed With Computational Modeling And Simulation

The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for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.

FDA Guidance Documents

FDA Final Guidance On BPH Device Studies Suggests Swift Patient Follow-Up

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.

Guidance Documents FDA
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