Early last week, FDA did something unexpected: it proposed accelerating the product approval process. Granted, the proposal—Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions—would apply to a select group of devices meeting strictly defined conditions. Still, many in the industry hailed it as a step in the right direction for an agency that is often pilloried for its glacial pace.
vitalsThe proposal is modeled after expedited review programs for pharmaceuticals, and it seeks to encourage early interaction during product development between companies and regulators. FDA welcomes public comments on the proposal on its website through July.
MedCity News published a good summary of the proposal, "FDA medical device proposal would develop faster path to market for breakthrough tech."
The announcement on April 24 that orthopedics manufacturer Zimmer agreed to acquire crosstown rival Biomet reverberated well beyond Warsaw, IN, the so-called "orthopedic capital of the world," where both companies are headquartered.
Valued at $13.35 billion, the deal would "dramatically reshape the orthopedic landscape," reported MassDevice.com, and make Zimmer/Biomet the second largest pure-play orthopedics company in the world, right behind Johnson & Johnson subsidiary DePuy Synthes and ahead of Stryker. "The transaction positions the combined company as a leader in the musculoskeletal industry with a broad portfolio of products, technologies and services, enabling us to help shape how solutions are developed and delivered," said Zimmer President and CEO David Dvorak in a prepared release.