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

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

(FDA) Center for Food and Drug Administration for Devices and Radiological Health (CDRH) on guests from industry, universities and health care to participate again in a program that helps train device personal opinion doctor .
Training Program (PEL) General 2015 Program Experiential Learning, which was first launched in September 2011, aims to provide staff CDRH a better understanding of the policies, practices and challenges of development cycle living laboratory apparatus.

"These visits formal training are not intended for the FDA to inspect, evaluate, judge, or performing a regulatory function (for example, inspection of compliance), but rather an opportunity to provide the review staff CDRH a better understanding of the products we reviewed, "the agency said in a Federal Register notice. "With this opinion, CDRH formally requests the participation of companies, universities and medical centers, including those who have already participated in other business programs the FDA or PEL available."
The program, which was officially launched in April 2013 and then extended and extended again a year later to include 34 new fields of interest, much of which has been associated with in vitro diagnostic technology and manufacturing.

New areas of interest:

Now the Office of Device Evaluation Review wants his staff to focus on eight new themes, including: Device Evaluation Office - new areas of interest

• A proof of biocompatibility
  Decision-making process for evaluating and selecting the biocompatibility test (if necessary); considerations for the use of animal testing in vitro tests against; Sample preparation at the nanoscale, bioabsorbable, and the in situ polymerized materials; color additives evaluation.
   
• Combination productsDevices coated with drug (s) or organic (s); Products / administration of biological drugs.
  
• Methods of emerging manufacturing3D printing; making additives; additional activities or single validation and verification.
  
• Device clinical trial managementThe conduct of clinical trials, to overcome common obstacles to initiate and complete clinical trials and interaction with other stakeholders; the preparation of applications for the authorization to conduct investigational device exemption (IDE) clinical studies and respond to comments received from the FDA.
  
• Reprocessing and SterilizationReprocessing challenges in clinical settings, including understanding of the techniques and incorporating these challenges in the clinical setting for studies on labeling and validation; cleaning validation techniques instructions, disinfection or sterilization; challenges in cleaning instructions validation, disinfection or sterilization; using simulation tests, especially for validating sterilization procedures and instructions; unique sterilization methods (for example, using flexible bags, sterilizing mixed sound waves, ultraviolet light, microwave radiation).
  
• Development of in vitro diagnostic (IVD)Pre-analytical devices (ie, blood tubes) of the collection devices pathogen Micro Devices collection / transportation; General reagents, reagent manuals; testing in general, the point of common focus devices.
  
• Medical devices Instrument TrainingThe practical training of the instrument and the system; clinical implication of common laboratory tests; hands-on familiarization of medical imaging equipment in a hospital.
  
• Quality system in manufacturing environmentsThe observation of practices implemented systems based on Good Manufacturing Practices quality; manufacturing medical imaging technologies therapeutic radiology.

FDA says it will pay for the travel expenses of its employees at sites, all of which "should have a successful record of compliance with the FDA or other institution with which the FDA has concluded a Memorandum of Understanding."