FDA’s Guidance Clears Up Factors, Benefits and Risks for IDE Submissions
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
Tag Archives: IDE
FDA Issues Draft Guidance on IDE Devices to Help with CMS Coverage Decisions
Should your IDE device be reimbursed? FDA’s latest draft guidance will help CMS make the decision.
Seeking Reimbursement During IDE Clinical Trials
Billing in clinical trials has changed recently, so here is a summary of where it has been and where it is heading.
Billing in clinical trials has changed recently, so here is a summary of where it has been and where it is heading.
Recent Pre-Market Activities at FDA
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.
Form versus Function in Medical Design
While safety and efficacy are prime drivers, a med-tech product’s form and its function have a much deeper and stronger relation than one might assume.
Beyond the Patient – The Recipe for a Successful Product
As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.
As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.
