FDA Lays Out New Areas of Interest for Training Device Review Staff

Posted 13 November 2015 | By Zachary Brennan

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia, and health care facilities to participate again in a program that helps train medical device review staff.

The 2015 Experiential Learning Program (ELP) General Training Program, which was first launched in September 2011, is intended to provide CDRH staff with a better understanding of the policies, laboratory practices and challenges of the device development life cycle.

"These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide CDRH review staff a better understanding of the products they review," the agency said in a Federal Register notice. "Through this notice, CDRH is formally requesting participation from companies, academia, and clinical facilities, including those that have previously participated in the ELP or other FDA site visit programs."

The program, which was officially launched in April 2013 and later expanded, and then expanded again a year later to include 34 new areas of interest, much of which was linked to in vitro diagnostics and manufacturing technology.

New Areas of Interest

Now the Office of Device Evaluation wants its review staff to hone in on eight new topics, including:

Office of Device Evaluation – New Areas of Focus
Biocompatibility testingDecision making process for biocompatibility evaluation and test selection (if needed); considerations for use of animal testing vs. in vitro testing; sample preparation of nanoscale, bioabsorbable, and in situ polymerized materials; evaluation of color additives.
Combination productsDevices coated with drug(s) or biologic(s); drug/biologic delivery products.
Emerging manufacturing methods 3-D printing; additive manufacturing; additional or unique validation and verification activities.
Management of device clinical trialsConducting clinical trials, overcoming common obstacles to starting and completing clinical trials, and interacting with various other stakeholders; preparing applications to request approval to conduct Investigational Device Exemption (IDE) clinical studies and responding to feedback received from FDA.
Reprocessing and sterilizationReprocessing challenges in clinical environment, including techniques for understanding and incorporating these challenges from the clinical environment to labeling and validation studies; techniques for validating cleaning, disinfection, or sterilization instructions; challenges in validating cleaning, disinfection, or sterilization instructions; simulated use testing, particularly for validating sterilization methods and instructions; unique sterilization methods (e.g., use of flexible bags, mixed sterilants sound waves, ultraviolet light, microwave radiation).
Manufacturing of in vitro diagnostics (IVDs)Pre-analytical devices (i.e. blood tubes), pathogen collection devices, micro collection/transport devices; general reagents, manual reagents; general assays, common point-of-care devices.
Instrument training of medical devicesHands-on instrument and system training; clinical implication of common laboratory testing; hands on familiarization of medical imaging equipment in a hospital setting.
Quality system in manufacturing environmentsObservation of implemented quality systems practices based on current Good Manufacturing Practices; the manufacturing of medical imaging or therapeutic radiology technologies.

FDA says it will pay for the travel expenses for its employees to the sites, all of which "must have a successful compliance record with FDA or another agency with which FDA has a memorandum of understanding."

The agency also includes information on how to request to participate.

Federal Register Notice


Tags: data, Integrity

Categories: Regulatory News

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