Photos Snapped During FDA Device Inspections: Fair Game Or Agency Overreach?
This article was originally published in The Gray Sheet
Executive Summary
FDA says it has the authority to take photographs during facility inspections, citing decades-old non-medical-device-related legal cases as evidence – including Dow Chemical Co. v. US – but industry lawyer Robert Klepinski says FDA's reliance on the Dow case as a defense for snapping pictures doesn't pass muster. "The agency always cites the Dow Chemical case, wherein the EPA flew over [Dow's plant] with a helicopter or airplane and took pictures," Klepinski said, noting that "it’s absolutely ludicrous, a stupid case to cite" because FDA investigators don't inspect device firms from the air. Meanwhile, the agency doesn't have a policy in place that addresses investigators' personal cameras, such as phone cameras, which throws into question whether photos could unintentionally – or intentionally – fall into third-party hands. Also, device-maker Cynosure's VP of regulatory affairs, Connie Hoy, talks about how her company handles photo requests made by investigators.
You may also be interested in...
From Electronic Docs To FOIA Requests, FDA Lays Bare Its Process For Remote Regulatory Assessments
A document from the US FDA obtained by Medtech Insight advises medical device manufacturers on how a voluntary Remote Regulatory Assessment will unfold. RRAs are being conducted by the agency in lieu of on-site facility inspections because of the COVID-19 pandemic.
FDA Presses Domestic Manufacturers To Engage In Remote Regulatory Assessments In Lieu Of Inspections
A US FDA official says the agency’s taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical agency audits pre-COVID-19. But in the interim, some companies are being asked to participate in voluntary Remote Regulatory Assessments.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?