FDA is looking for new companies to test out its pre-cert pilot program
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
FDA considering imposing 10-year limit when manufacturers choose older predicates
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
Why Pharma Companies Should Look To Social Media For Better Patient Insight
Healthcare decision-makers, especially at pharmaceutical companies, must prioritize patient input. Data collected from social media listening is a significant step in the right direction.