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Category: Policies & Guidance

FDA OMHHE releases new video on medical device clinical trials

FDA’s Office of Minority Health and Health Equity released a new video about the importance of diverse participation in clinical research for medical devices. The FDA not only reviews new drugs, but the agency also reviews many medical devices before they are marketed to determine if they meet FDA’s safety and effectiveness standards. Diverse participation in clinical […]

New process for monitor access to EMR and patient records

COVID-19 has created many challenges and opportunities for clinical research over the last several months. One has been setting up the VCUHS site monitors with virtual access to our patient’s records.  There now is a solution in Cerner that is working for VCUHS monitors.  Now that it is known that the External Chart Auditor Cerner access […]

FDA adds 25 regulatory science tools to help assess medical devices

The U.S. Food and Drug Administration (FDA) added 25 tools to the Catalog of Regulatory Science Tools to help assess medical devices. The tools include: Laboratory Accuracy Evaluation of Infrared Thermographs Benchmark Problems for Verifying Cardiac Electrophysiological Models Use of Newtonian Analog Fluids And 3D Printing to Evaluate Flow Rates of Diets In G-Tubes Confocal […]

FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Read the guidance The final guidance: Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol. Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing. Provides consensus standard references and terminology to aid […]

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This document describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body: premarket approval applications (PMAs), humanitarian device exemption […]

NIH Guidance on Charging Personal Protective Equipment for Grants that Support Clinical Trials and Clinical Research

NIH has received many inquiries from recipients regarding their ability to direct charge personal protective equipment (PPE) costs to their clinical trials and clinical research awards. In this recent Guide Notice, NIH provides criteria for applicants/recipients on when it is appropriate to direct charge PPE costs. Note: This guidance applies to all applicants and recipients of […]

Recently Posted FDA Guidance Documents

9/25/2020 – Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 9/25/2020 – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation […]

Recently Posted FDA Guidance Document

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Link: www.fda.gov/media/142143/download

Recently Posted Guidance Documents

9/3/2020 – Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing and Labeling 9/2/2020 – Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry 9/2/2020 – Investigational COVID-19 Convalescent Plasma: Guidance for Industry 8/31/2020 – Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: […]

FDA Issues Revised Draft Guidance, “Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing”

(9/3/2020): The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry entitled, “Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing.” This revised draft guidance assists sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics and/or pharmacodynamics […]

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