Bringing a product to market in the United States can be complicated, but it can be streamlined with a clear grasp of the process.
FDA issues two new draft guidances that explain when device or software changes require a 510(k) submission.
The agency says there’s not enough evidence to demonstrate that there’s reasonable assurance of safety and effectiveness.
The acting commissioner reflects on the agency’s achievements in the last year.
If you climb into FDA’s sandbox, be prepared to play by the rules.
Regardless, let’s look at stupidity in its highest form.
Device establishments should be able to read and comprehend 21 CFR Part 807.
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
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.
The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?