510(k) ball back in US FDA's court - agency must not fault
This article was originally published in SRA
More compelling claims emerged this month that support those who want the US Food and Drug Administration to be bold in its review of the 510(k) route of device regulatory approval1.
You may also be interested in...
The disruptive medtech M&A of recent years was not matched in the past year for volume, but there were isolated outbreaks of major activity, as shown in our company rankings.
For providers and medtech manufacturers alike, the decade ahead will be a time of coming to terms with digital technologies and integrating new methods of payment. Quality of service delivery remains the market entry criterion, but companies will have to adapt to evolving health care delivery models. The stakes are implausibly high. Will they be able to capitalize on the changes in a market that is more competitive and unpredictable than ever?
The potential of China’s vast health care products market is alluring. It has proved off-limits to most of the global medtech industry, and is rarely in the early launch strategies of global companies. Government-led initiatives want that to change, as evidenced in the latest Five-Year Plan and the recent Healthy China 2030 report.