Sep 10, 2013

The US Food and Drug Administration plans on taking a more proactive approach to informing medical device companies when new scientific data changes requirements for premarket data submissions.

The FDA’s Center for Devices and Radiological Health (CDRH) has published a draft Standard Operating Procedure (SOP) lying out new procedures to notify industry participants via “Immediately in Effect” or IIE guidances whenever new scientific evidence affects data requirements for 510(k) premarket notification, Premarket Approval (PMA) and Investigational Device Exemption (IDE) submissions. IIE guidances would, according to the FDA’s Good Guidance Practices regulation, bypass prior public comment policies in order to address acute public health concerns.

Currently, individual US market registrants are usually informed on a case-by-case basis of any premarket data requirement changes only once their device reviews have begun. Dealing with requests for information such as new clinical data or testing methods based can prove time-consuming and expensive for manufacturers that have already invested time and money into preparing their FDA medical device premarket submissions.

The FDA is seeking comment on the proposed SOP before implementation. Providing public notice of changing regulatory requirements and expectations should alleviate frustrations and costs for some manufacturers, but US market registrants will also have to keep track of current premarket data requirements to avoid review delays. 

Stewart Eisenhart


  • Stewart Eisenhart