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USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices

Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and Radiological Health released an updated guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices".


In this draft guidance, FDA clarifies how it evaluates real-world data (RWD) to determine if they are of sufficient quality to support real-world evidence (RWE) in medical device regulatory decision-making.

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.


Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.


This draft guidance includes factors that FDA considers important to demonstrate whether the RWD are fit-for-purpose for a particular regulatory decision relating to medical devices, along with FDA's suggestions for assessing these factors. If this draft guidance is finalized, it will encompass the process of conducting studies to generate RWE and recommends and considers the recommendations and considerations regardless of the source of RWD.

The topics covered within this draft guidance are framed specifically for the use of RWD and RWE in regulatory submissions for medical devices. eg:

  • Investigational Device Exemption (IDE)

  • premarket notification under section (k) of the FD&C Act

  • Premarket Approval Application (PMA)

  • Humanitarian Device Exemption (HDE)

  • De Novo classification request

  • post-approval study

  • postmarket surveillance under Section of the FD&C Act ( submissions)

  • Clinical Laboratory Improvement Amendments (CLIA)

  • Waiver by Application (CW)

  • Dual De Novo/(k) and

  • CLIA Waiver by Application Submissions (Duals)


FDA recognizes that RWE can be generated from a variety of RWD sources that are primarily intended for another purpose. For example, administrative claims data are typically collected for purposes of billing or payment for medical care.


To know more in detail about the Considerations for Methodologies for Collection and Analysis of RWD to Generate RWE, etc click this LINK.


There was another guidance "Clinical Pharmacology Considerations for Peptide Drug Products" released on the same day for comments. This guidance provides recommendations to assist industry in the development of peptide drug products and once final will describe the FDA’s current thinking regarding the impact of clinical pharmacology considerations, including hepatic impairment, drug-drug interactions (DDIs), QTc prolongation risk, and immunogenicity risk on a peptide drug product’s pharmacokinetics (PK), safety, and efficacy.


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