I was reminded this month that the FDA is the regulatory body for a wide variety of radiation-emitting products available in the U.S. when I received this notice of the final guidance "Classification and Requirements for Laser Illuminated Projectors”. That’s right,...
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The User Experience is Critical to Software Success
Why Isn’t this Obvious?I participated in a commercial webinar last week about improving clinical trial data acquisition, patient participation, and treatment compliance using mobile applications with a thoughtfully designed user experience (UX). The presenters...
Help FDA Track RWE by Identifying Its Use in Drug Submissions
In a previous post I discussed the FDA’s Framework for Real World Evidence program. The latest update to this program is a draft guidance intended to encourage sponsors submitting INDs, NDAs, and BLAs that use Real World Evidence (RWE) to support a regulatory decision...
Patient Preference Information for Medical Devices
Patient Preference Information (PPI) is one type of patient feedback that provides assessments of the desirability or acceptability of different treatment alternatives. This information shows the value attributed to different aspects of each alternative and it can be...
Development and Submission of Near IR Analytical Procedures
Draft guidance was issued in March on the development and submission of near infrared (NIR) analytical procedures for use during the manufacture and analysis of pharmaceuticals. NIR is a spectroscopic technique that uses wavelengths of light just below the visible...
What are the Least Burdensome Approach for Medical Devices?
CDRH hosted a webinar on March 14th to review the current state of the Least Burdensome approach following issuance of an updated final guidance on February 5, 2019. The purpose of the approach is the remove or reduce unnecessary burden during the regulatory process...
Updates to the FDA’s Web Page May Mean Broken Links in Posts
I’ve recently noticed some updates to the FDAs web pages that may mean some broken links in my previous posts. When you click on some links, you will see the notification shown above (see an example by clicking here). I’ve been able to find the resources by copying...
CDRH forms the Office of Product Evaluation and Quality
Readers will recall my previous post on the reorganization of CDRH to create a more adaptive structure to meet future needs. As part of that reorganization, the Office of Product Evaluation and Quality (OPEQ) was launched on May 1st, 2019 (see the announcement here)....