FDA has issued final guidance on “Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects.” The guidance document is now available from FDA’s website at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf The clinical trial investigator responsibilities within the FDA regulations are specific but, at the same time, limited in depth. This guidance document expands FDA regulations by … continue reading
I recently attended the “Human Factors for Medical Devices” course sponsored by the Association for the Advancement of Medical Instrumentation (AAMI). The three-day program provided an introduction to human factors, discussion of FDA regulatory requirements related to human factors, and the role of human factors in design controls. Among the faculty was Ronald Kaye, Human … continue reading
On August 6, Dr. Margaret Hamburg, Commissioner of Food and Drugs, outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations at a speech to the Food and Drug Law Institute. In her speech Dr. Hamburg outlined plans for enhanced FDA enforcement of violations. … continue reading
The following news item about an FDA Regulations Fundamentals training presented in part by two MDCI staff, appeared in the most recent MassMEDIC newsletter. The training was well attended and similar grant-funded medical device issues trainings are in the works. “MassMEDIC held a two-day training session on the fundamentals of FDA regulations on August 4-5 … continue reading
MDCI read with interest the August 3 article in the Gray Sheet, “510(k) Sponsors Should Be Wary Of Informal Talk with FDA“. Our experiences with the consequences of basing critical regulatory strategy decisions on informal communications with FDA are similar to those presented in the article by John Smith of Hogan & Hartson. In fact, … continue reading
The FDA regulatory pathway for commercializing medical devices can be a maze of mandates which, if disregarded, can slow time to market, inflate design and development costs, and even result in complete product withdrawal. Being prepared with a smart regulatory strategy and knowledge of the ins and outs of the FDA regulatory process and requirements … continue reading
For anyone planning to submit a 510(k) or other premarket submission to the Center for Devices and Radiological Health (CDRH) this summer, be aware that the Agency’s planned move to the new White Oak facility may add a few extra days to your project time line.The FDA announced today that there will be a temporary … continue reading
Today, the FDA published a notice about the reclassification of 25 preamendment Class III medical devices, all marketed prior to 1976, for which regulations requiring submission of premarket approval applications (PMAs) have not been issued. The FDA is seeking information to evaluate the risk-level of each type of device and determine if the devices should … continue reading
