FDA Law Blog
FEBRUARY 9, 2024
Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.
FDA Law Blog
JANUARY 4, 2023
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
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FDA Law Blog
FEBRUARY 7, 2023
Part 814), and for conducting clinical trials (21 C.F.R. Or, to put it another way: We have not yet met an engineer who enjoys remediating the documents for development work that was done in the past. Second, if clinical data will be needed to support the marketing application, compliance with design controls is required.
FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
FDA Law Blog
JULY 10, 2023
In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.
FDA Law Blog
DECEMBER 15, 2024
For tissue-engineered medical products, examples may include biomechanical testing to assess the ability of a vascular graft to tolerate repeat access without leaking, permeability testing to assess the characteristics of a skin graft, or cellular distribution throughout a cell scaffold construct.
FDA Law Blog
OCTOBER 6, 2022
The Agency recommends determining the process requirements early in the development process because late changes in the development program will introduce uncertainty later that may result in a clinical hold. In addition, they should know how to control for analytical method variability prior to starting the clinical trial.
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