Clinical Research Solutions
FDA Considers Moving Medical Device Submissions to Electronic Format
On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...
Clinical Research Solutions
FDA Releases Draft Guidance on Benefit-Risk Determinations for Devices
On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...
Clinical Research Solutions
FDA Drafts List of Device Accessories to be Reclassified into Class I
On Thursday, August 16th, the FDA released a list of medical device accessories that have the potential to be reclassified as class I devices. Background According to section 513 of the Food, Drug, &...
Clinical Research Solutions
FDA’s Final Rule Sets GCP Standards for Medical Device Trials Conducted Outside US
On Wednesday, February 21st, the FDA released a final rule entitled “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The new rule amends the Agency’s...