Clinical Research Solutions
FDA Announces Plans to Modernize its 510(k) Medical Device Approval Process
On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the "clearance of low- to...
Clinical Research Solutions
FDA Grants Two Mobile Medical Applications to be Used with the Apple Watch
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
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FDA Releases Draft Guidance on Benefit-Risk Determinations for Devices
On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...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...