Much has changed in the FDA over the past year, and more change is to come. While suggestions are being taken by FDA, their position seems clear that “Strengthening the 510(k) Review Process” means getting tougher on industry. For a recap of the historic meeting check the Five-Ten Blog post.

Despite Hamberg's FDA continuing to toughen its approach, the agency is still facing increased scrutiny from those critical of its past efforts. Even though these critics claim to be advocating for the patient, FDA's reaction may stifle innovation to the detriment of very this same group. Read today's Five-Ten blog about the latest groups to challenge the FDA, and how it may affect the device makers in the industry.