Understanding, keeping track of and interpreting everything that comes out of the US Food and Drug Administration (FDA) is a difficult job. We should know-it's literally our job here at Focus. But even as we read every regulation, thumb through every guidance and digest every guidance document, compliance policy guide, speech, Warning Letter and document we can get our hands on, there's still much that we don't have access to.
FDA admits as much in a new Federal Register posting focusing on its Center for Devices and Radiological Health (CDRH), its device regulation division which has received more than a few complaints in recent years about its perceived lack of transparency.
The problem, explains FDA, is that even when it releases a guidance document, that document may well reflect formal agency policy years after it is first put into informal practice at the review level. It is not, in other words, as though a switch is flipped and all of a sudden regulators begin to regulate within a particular framework. Rather, it is built up over time in light of experience, trial and error, eventually becoming official practice.
But therein lies a problem: Due to agency resource restrictions, it can be a long and arduous process to get a guidance document, regulation or compliance policy guide published for industry consumption. In the meantime, industry may still be operating under an assumption that the status quo framework is still in effect, when in fact a more current one is the de facto standard.
So how do you bridge the gap between unstated official policy and actually issuing guidance to industry? That very question was before FDA's Task Force on the Utilization of Science in Regulatory Decision Making in 2010, and the group ultimately released a report calling on CDRH to do a better job communicating when new scientific information resulted in a change in regulatory policy within the center.
FDA noted the recommendations included more rapid tools for communication, broader communication, and standards for communicating to specific subsets of manufacturers. Due to the length of many clinical development programs, especially for complex and high-risk devices, rapid communication is particularly important in order to minimize any disruptions in the development process.
Said FDA: Currently, manufacturers typically learn of changes CDRH implements regarding what data or how to gather specific data in support of an Investigational Device Exemption (IDE) or premarket submission, including a Premarket Notification 510(k), a Premarket Approval application (PMA), or an Humanitarian Device Exemption (HDE) at the time of or soon after a decision is made through individual engagement with the Center, often not until after they have prepared that submission.
Bite-Size Regulatory Guidance
Instead of the current paradigm, FDA said it will begin to issue what it calls Level 1, IIE guidance documents "when prior public participation is not feasible or appropriate."
While FDA put out a draft Standard Operating Procedure (SOP) on the practice of releasing so-called "Notice to Industry" letters (instead of Guidance for Industry) in 2011, it has now revised that SOP in order to address "concerns" raised by industry.
The new draft, Draft Standard Operating Procedure (SOP): Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues, contains much that should be familiar to industry. For example, the documents will still be released through regular Federal Register postings. The only difference, FDA explained, will be the speed relative to the policy change.
Notices to Industry will be developed based on three criteria being met:
- New scientific information has been identified that raises new risk/benefit information.
- FDA's regulatory expectations change as a result of (1).
- Public comment is not feasible based on time constraints.
If these criteria are met, CDRH staff will meet with the Center Science Council (CSC) to brief the council and to explain why changes are both necessary and proper, and why a IIE guidance document is the best course of action.
After an evaluation process, the Notice to Industry will be developed.
Short, Quick and (Hopefully) Useful
The good news for industry: These documents will be relatively short compared to typical guidance documents, weighing in at just 1-2 pages "and generally no more than three pages in length." Typical guidance documents are often several times as long and go into depth on specific requirements generated through a public comment process.
While a comment process will not be available before IIE implementation, it will be available after its release for 60 days, allowing industry to weigh in for the development of an eventual guidance document on the subject. Those guidance documents "should be issued 90 days after the initial comment period closes," FDA explained.
That should, in theory, allow industry an additional round for weighing in on proposed guidance beyond what it now enjoys.
In the meantime, if you're interested in commenting on FDA's SOP on Advisory Letters for Industry, the agency says it's accepting comments until 21 October 2013.
Federal Register Notice
Draft SOP on IIE Guidance
2011 Draft SOP