FDAnews Announces Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers Management Report

Use of real-world data and evidence is rising. Understand how to use both in premarket and postmarket obligations. Order today.

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Dec 14, 2021, 15:00 ET

FALLS CHURCH, Va., Dec. 14, 2021 /PRNewswire-PRWeb/ -- Using Real-World Evidence in FDA Submissions:
A Guide for Devicemakers
FDAnews Management Report
https://www.fdanews.com/products/61950

The FDA has been clear: it wants medical device submissions that increasingly rely on real-world evidence (RWE).

Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers is essential. It will prepare readers for everything one must know and do to develop new products using RWE, including how to prepare successful premarket and postmarket submissions and get a device approved.

The dissection of nine real-life examples of devicemakers that used RWE in their successful FDA submissions are key to what makes this volume essential, coupled with its clarification of the FDA's 2017 guidance and policy statements, and explanation of the key criteria for effective RWE — relevance, reliability, accuracy.

Using Real-World Evidence in FDA Submissions explains how to use RWE to demonstrate a device's effectiveness and safety, empowering one to understand and use it to one's advantage, including:

  • How to evaluate real-world data (RWD) to determine whether it is sufficient to generate the types of RWE that can be used to support regulatory decisionmaking for medical devices
  • When RWE meets the criteria for valid scientific evidence
  • Benefits of using medical device registries as a postmarket control
  • How RWE can supplement or even replace data generated by traditional clinical trials
  • Purposes for which RWD can be used
  • General examples of how RWE can be used (e.g., expanded indications, postmarket surveillance, control groups, objective performance criteria)
  • Challenges in using RWE

Success is steps away when one uses RWE to strengthen applications. Find the RWE roadmap in Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers.

Management Report Details:
Using Real-World Evidence in FDA Submissions:
A Guide for Devicemakers
FDAnews Management Report
https://www.fdanews.com/products/61950

Price:
$397

Easy Ways to Order:
Online: https://www.fdanews.com/products/61950
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

Media Contact

Michelle Butler, FDAnews, 703.538.7600, [email protected]

SOURCE FDAnews