When it comes to compliance, the FDA does not grant special dispensation.
Device establishments must maintain records of acceptable suppliers.
If an activity is not documented, it did not happen.
The agency wants to modernize its regulatory processes and make them more efficient.
The Inspiris Resilia valve is intended for aortic valve replacement.
The agency has cleared expanded use of the DigniCap for solid tumor cancers beyond breast cancer.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
Used with flow cytometry, this is the first agency-authorized test to detect several leukemias and lymphomas.
The initiative also focuses on how devices will be regulated in the post-market world.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.