Keeping Up With CDRH: New Draft SOP for Guidance Documents on Premarket Data Issues (Our 2,000th Post!)

By Allyson B. Mullen –

Have you ever heard of an “Immediately in Effect (IIE)” guidance document?  Thanks to a new draft SOP issued by CDRH, you may soon see this new species of guidance on a regular basis.

In section 405 of Food and Drug Administration Modernization Act of 1997 ("FDAMA"), FDA was authorized to issue guidance documents without public comment in certain circumstances.  Specifically, section 701(h)(1)(C) was added to the Food, Drug, and Cosmetic Act (the “Act”) and states that guidance documents “set[ting] forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues” must have prior public participation before implementation “unless the Secretary determines that such prior public participation is not feasible or appropriate.”  (Emphasis added.)

In February 2000, FDA issued proposed implementing regulations.  The preamble to the proposed regulations suggests that FDA deems prior public participation “not feasible or appropriate” if: “(1) there are public health reasons for immediate implementation of the guidance document; (2) there is a statutory requirement, executive order, or court order that requires immediate implementation; or (3) the guidance document presents a less burdensome policy that is consistent with public health.”  65 Fed. Reg. 7321, 7324 (Feb. 14, 2000).  The proposed regulations were finalized in September 2000 and are codified at 21 C.F.R. § 10.115(g)(2). 

Nearly 13 years later, on September 5, 2013, CDRH announced a Draft Standard Operating Procedure ("SOP") “Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues” (the “Draft SOP”).  78 Fed. Reg. 54655 (Sept. 5, 2013).  Some may wonder why FDA would propose an SOP setting forth the process for issuing guidance at this late date.  Could it be because they are intending to make greater use of such a process and implementing more written guidance without prior public participation?

The stated intent of the Draft SOP is to clearly and efficiently communicate changes in CDRH’s expectations and new scientific information that relate to or could impact Investigational Device Exemptions and pre-market submissions (e.g., 510(k)s, PMAs, HDEs).  Draft SOP at 1. The Draft SOP accomplishes this objective by creating a new category of guidance document, called, “Immediately in Effect (IIE) Guidance Documents.”  Id. at 1.  (The Draft SOP replaces CDRH’s earlier attempt in 2011 to establish such a process in its “‘Notice to Industry’ Letters” SOP. 78 Fed. Reg. 54655.)

The Draft SOP proposes a three-pronged assessment to determine if an IIE Guidance Document should be developed: (1) there is new scientific information identified, which raises “new, important safety risk or calls into question the adequacy of currently used test methods or clinical trial design to demonstrate or bear on safety, effectiveness, and/or substantial equivalence of a device type;” (2) as a result of such new information, CDRH needs to change its regulatory expectations  with respect to IDEs and premarket submissions; and (3) “prior public participation is not appropriate or feasible.”  Draft SOP at 2. 

Based on these criteria, it appears as though there could be a high bar for issuance of an IIE Guidance Document.  However, the Draft SOP does not define or put any parameters around what would constitute new scientific information (must it be actual or speculative?) and FDA has previously declined to limit the use of IIE Guidance Documents to “rare and extraordinary circumstances” or “where there is a real demonstrated public health emergency, not just a theoretical emergency.”  65 Fed. Reg. 56468, 56472 (Sept. 19, 2000). 

It seems possible that CDRH could be planning to put this SOP into routine use once finalized since the Draft SOP provides a fairly simple process for issuing IIE Guidance Documents.  The Draft SOP allows for CDRH staff and management to prepare a briefing summary for discussion of proposed IIE Guidance Documents with the Center Science Council ("CSC").  Draft SOP at 3.  The Draft SOP includes a sample (short) format for a briefing summary and states that the briefing summary should include 9 items:

• The new scientific information;
• How the risk/benefit profile of the particular device is changed by the new scientific information;
• The Center’s anticipated changes to regulatory policy in light of the new scientific information;
• Why such changes are necessary;
• The audience who should be made aware of such changes;
• The submission types affected by such changes (future and/or pending submissions) (Yes, you read that correctly – IIE Guidance Documents can impact not only future submissions, but also submissions pending with CDRH at the time the guidance is issued; how will companies keep up?);
• The existing guidance documents impacted by such changes;
• Why an immediate effect guidance document is the “only appropriate method for disseminating this information”; and
• Whether and to whom any further communication regarding the topic at issue is needed.  Id. at 3 & 7.

Based on the discussions facilitated by the briefing summary, the CSC is charged with determining whether the new scientific information warrants a change in the premarket regulatory expectations, whether the change should be communicated through an IIE Guidance Document, and whether additional expertise is needed before making a determination on a particular topic.  Id. at 3-4.

Once the CSC determines that an IIE Guidance Document should be issued, the guidance is drafted and should only be 1 to 2 pages in length, and generally not exceed 3 pages.  Id. at 4.  For information that is critical to industry, such as changing regulatory expectations, it seems that it may be difficult for CDRH to include all of the required elements (e.g., the nonbinding language disclaimer) and still find space in three pages (maximum) to clearly articulate its new expectations.  Once drafted, the IIE Guidance Document must be approved by a number of individuals within CDRH before it is published in the Federal Register.  Id. at 5.  Lastly, the Draft SOP provides for public comment during the 60-day period following issuance of the IIE Guidance Document; and in the 90 days following close of the comment period, CDRH will review the comments and revise the IIE Guidance Document, if necessary.  Id. at 5.
 
Only time will tell how CDRH will utilize this SOP, and whether it will become routine.  However, it appears as though CDRH is establishing a simple process to easily implement guidance without public input and without establishing parameters around critical steps in the process (e.g., what constitutes new scientific information).  Since when does a bureaucracy invest significant effort in developing a regulatory tool and then choose not to use it?  The odds are that you will soon become very familiar with IIE Guidance Documents.