FDA Releases Draft Guidance on the PMA (written by Laura Uzdienzski @ HealthPointCapital)
Furthering its efforts at transparency in its regulatory processes, the FDA released new draft guidance on Monday regarding clinical study expectations for medical devices.
According to data from 2008-2010, the FDA has struggled to meet its MDUFA objectives of reviewing PMA applications within 180 days. During that two-year period, only 37 of 85 submissions, or 56%, were reviewed within the 180-day timeframe. The new guidance may help to accelerate that time horizon or minimize the back-and-forth between the agency and manufacturers, providing an overview on multiple aspects of study design, including:
- Types of studies
- Patient and site selection
- Bias and variability
- Surgeon skill and learning curve
- Patient follow-up
- Changes to the protocol
- Data handling and analysis
CDRH Director Jeffrey Shuren said that the guidance is intended to help manufacturers “take the least burdensome approach” to FDA approval. He also encourages companies to contact the FDA to clarify data needs and ensure the most “practical” approach to market.