viernes, 29 de enero de 2016

FDA Law Blog - The Perils of Being a Store Clerk in an FDA-Regulated World; Additional Time Granted for Comments on Draft Emerging Signals Guidance

Posted: 28 Jan 2016 03:56 AM PST
By Melisa M. Moonan –
FDA has granted stakeholders an additional 30 days to comment on its the December 31, 2015 draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” The new deadline for comments is March 29, 2016.   We previously commented on the significant issues raised by this draft guidance here and in relation to User Facility MDR inspections here.
FDA stated in its announcement of the extension that it was “taking this action due to the unanticipated high-level of interest from external stakeholders and the medical device community[.]”  We are baffled by FDA’s lack of anticipation of stakeholder interest. Considering the risks for manufacturers, users, and patients of  FDA publicly communicating theoretical risk information about emerging signals that have not been fully analyzed or confirmed, this high level of interest was foreseeable.
The extension appears to respond to requests for an additional 30 days to comment by two industry groups, AdvaMed and the510(k) Coalition.  The grounds are unsurprising to us, and accord with the concerns we noted in our blogpost on the draft guidance.   AdvaMed ’s request stated that the draft guidance “represents a significant departure from the Agency’s current postmarket communication policies” and requires consideration of the potential impact across a broad range of products that have a variety of indications for use and use settings.  The 510(k) Coalition’s request similarly stated  that the draft “represents a significant change,” from current policy and process and presents “complex legal and regulatory issues and public health implications.”   
Given recent Congressional and press interest in FDA’s efficiency in communicating public health issues,  interested stakeholders should submit their comments by the new deadline.  We do anticipate that finalizing the Emerging Signals guidance will be a high-level priority for the agency.

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