The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
The FDA’s rules for clinical investigators cover a lot of ground, from how to avoid financial conflicts of interest, to delegating investigator authority to other members of the trial team, to hiring—and sometimes firing—investigators under your charge. The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but even those documents can’t answer every question you may have about the people who actually conduct the trial.