Release of Proposed IMDRF Document: Definitions for Personalized Medical DevicesPublished on May 23, 2018
Author: Bhavesh Patel, C. Chem.
The International Medical Device Regulators Forum (IMDRF) recently published a Proposed Guidance Document titled Definitions for Personalized Medical Devices (the “Guidance”). The Document is open for public consultation and has been posted on the IMDRF website for comments from the public.
The purpose of the Guidance is to harmonize definitions used to describe medical devices intended for a particular individual. The adoption of consistent, harmonized definitions for such medical devices could underpin a harmonized regulatory approach for controls on these devices and offer significant benefits to the manufacturer, user, patient, and to regulatory authorities. Eliminating differences between jurisdictions supports global convergence and decreases the cost of gaining regulatory compliance. The potential reduction in regulatory red tape will also allow patients to gain earlier access to new technologies and treatments.
This consultation will close on Thursday, May 24, 2018. The comment template can be find here.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....