When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?
On May 3, 2019, FDA established a docket to collect public input on a proposed list of patient preference-sensitive areas for medical device review, and posed certain related questions (comments are due July 2, 2019). By identifying these key areas (which it committed to as part of the reauthorization of the Medical Device User Fee ...
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability... [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]
FDA regulates medical ...
Blog Editors
Recent Updates
- CMS Tells States “No More” Medicaid Section 1115 Matching Funds for Designated State Health Programs (DSHP) and Designated State Investment Programs (DSIP)
- Podcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care
- A Closer Look at Proposed Changes to Medicare Advantage in the “No UPCODE Act”
- Green Commercial Leases
- Podcast: Criminal Health Care Fraud Enforcement - Projections for 2025 and Beyond – Diagnosing Health Care