What’s New at CDRH?

Since January 1, it seems that the Center for Devices and Radiological Health (CDRH) has been out of the agency’s spotlight, and even FDA’s “News & Events” webpage has been lacking in its reporting of medical device related activity.  This is not to say that there have been no recent developments in the last eighteen days. On the contrary, there have been several notable developments relevant to the regulation of medical devices:

1. Custom Devices. On January 14, 2014, FDA issued a draft guidance entitled “Custom Device Exemption Draft Guidance for Industry and [FDA] Staff.”  In this draft document, FDA provides guidance about implementation of the custom device exemption.  The guidance provides draft definitions of terms used in the custom device exemption, explains how FDA proposes to interpret the “5 units per year of a particular device type” language contained in section 21 U.S.C. §360j(b)(2)(B), describes what information FDA proposes should be submitted in a Custom Device Annual Report (annual report), and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption.
2. Pediatric Information requirements for PMAs.  On January 10, 2014, a final rule was published in the Federal Register regarding the Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or a Condition that a Device is Intended to Treat, Diagnose, or Cure.  Put simply, FDA has amended 21 C.F.R. Part 814, Premarket Approval of Medical Devices, to include requirements relating to the submission of “readily available” information on pediatric subpopulations (defined as twenty-one years of age and younger) that suffer from the disease or condition that a device is intended to treat, diagnose, or cure.  The rule defines “readily available” as available in the public domain through commonly used public resources for conducting biomedical, regulatory, and medical product research but the FDA mentions in its final rule preamble that it intends to issue guidance to explain the agency’s current thinking on the meaning of “readily available information.” Although the term is not well defined and subject to reinterpretation, FDA has indicated that the absence of such “readily available” information in the application will be potential cause for denial.  The final rule is effective April 10, 2014.
3. Blood Glucose Meters. On January 7, 2014, FDA issued two draft guidance documents regarding blood glucose meters. FDA recognizes two distinct settings for typical use of blood glucose meter devices in the two guidance documents: self-monitoring using devices purchased over-the-counter, and use in a clinical setting by health care professionals.  FDA justifies separate guidance documents because meters used in these different settings have “unique characteristics and different design specifications.”  For example, critically ill patients in health care settings may have physiological variables, like abnormal oxygen levels that could interfere with the accuracy of the blood glucose meter.  The draft guidance documents set forth recommendations regarding the labeling, performance evaluation, manufacturing controls, and cleaning and disinfection procedures of blood glucose meters to help improve accuracy and reliability.  Comments on these draft guidance documents are due on or before April 7, 2014.

In addition to the above, there have also been pronouncements in the Drugs and Biologics realm which may also potentially impact upon medical device firms:

1. On January 14, 2014, FDA announced the availability of a new Draft Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.  While not directly applicable to medical devices, this draft guidance may be helpful in understanding how CDRH may view similar interactive promotional materials for medical devices.  The draft Guidance is intended to inform drug sponsors of when postmarket reporting obligations are triggered by blog posts, microblogs, social networking sites, online communities, live podcasts, and other internet postings.
2. On January 9, 2014, FDA published on its website a Warning Letter to a dietary supplement firm for making various drug claims.  FDA cited that the company coded its website with “metadata” or “tags” that contained unlawful drug claims.  This is an interesting development because metadata is not visible to a consumer on the actual webpage and, instead, is used to direct consumers to the website if certain terms were searched.   Again, this is not directly applicable to medical devices, but it is instructive in how FDA may look at or view metadata on a promotional webpage.

Despite its silence, CDRH has been busy in the first eighteen days of 2014. We are hopeful that this activity may portend the release of the long-awaited final rule for electronic Medical Device Reporting (proposed rule was published in August 2009). We shall see.