White Papers
White Paper – FDA Guidance Documents for De Novo Classification Requests
The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification. On October 4, 2021, the US Food and Drug Administration (FDA)...
White Paper – Transition Plan for COVID19 EUAs
White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency. The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the...
White Paper – Proposed QMSR Expert Analysis (Part 2)
On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 2 of a series of...
White Paper – Proposed QMSR Expert Analysis (Part 1)
On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 1 of a series of...
Risk Management Series – Article 7 Part A: Determining Risk Acceptability
In our last two articles, Part 5: Assigning Harms and Severity and Part 6: Estimating Probability of Occurrence, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes...
Risk Management Series – Part 6: Estimating Probability of Occurrence
In our last article, Part 5: Assigning Harms and Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and...