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Regulatory Update, December 2016

Thursday, December 1, 2016

FDA Publishes Final Guidance Documents

The FDA published these final guidance documents. Interested parties may submit electronic or written comments on these guidance documents as instructed for the first document and with the indicated Docket Number included in the comments.

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

In the October 11, 2016 Federal Register, the FDA announced the availability of the final guidance titled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This document describes studies and criteria that the FDA recommends be used when submitting a premarket notification [510(k)] for blood glucose monitoring systems (BGMS) that are for prescription point-of-care (POC) use in professional healthcare settings. The FDA intends for this document to serve as a guide for manufacturers in conducting ap­propriate performance studies and preparing a submission for these device types. This doc­ument is not meant to address self-monitoring blood glucose test systems (SMBG) for over-the-counter (OTC) home use by lay-users.

Historically, the FDA has not recommended different types of information in submissions for BGMS used by healthcare professionals as compared to SMBG intended for home use by lay-users. However, it has become clear to the FDA that these different use settings have distinct intended use populations with unique characteristics that can have an impact on device design specifications. Manufacturers should take these characteristics into account when designing their devices. To distinguish FDA recommendations for prescription-use blood glucose meters, which are intended for use in POC professional healthcare settings, and SMBG devices intended for home use for self-monitoring by lay-persons, the FDA is is­suing two separate guidance documents for these device types. The FDA believes that in making this distinction, BGMS can be better designed to meet the needs of their intended use populations, thereby providing greater safety and efficacy.

Because BGMS are used in professional healthcare settings, they are more likely to be used on multiple patients. The Centers for Medicare and Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) have expressed concern over the pos­sibility that blood glucose meters can trans­mit blood-borne pathogens if these devices are contaminated with blood specimens and shared between users without effective clean­ing, disinfecting, and appropriate infection control measures. This document describes certain design features and capacity for clean­ing and disinfection to prevent the spread of blood-borne pathogens.

In addition, concerns have been raised cit­ing the inability of currently marketed BGMS to perform effectively in professional health­care settings because these devices have not been adequately evaluated in some of the populations in which they are being used. Pa­tients in professional healthcare settings are often fundamentally different than lay-users using these devices at home. Patients may be acutely ill and medically fragile and are more likely to present physiological and pathologi­cal factors that could interfere with glucose measurements relative to lay-users. Errors in BGMS accuracy can lead to incorrect insulin dosing, which when combined with other fac­tors, can lead to increased episodes of hypo­glycemia. For hospitalized patients who may be seriously ill, glucose meter inaccuracies could further increase risk to health. This document describes studies that can be con­ducted to demonstrate BGMS performance for devices intended to be used in diverse professional healthcare settings on subjects in various states of health. While the FDA rec­ommends that the information described in this guidance be included in premarket sub­missions for BGMS, submissions containing alternative information may be sufficient if able to demonstrate substantial equivalence to a legally marketed predicate device.

Interested parties may submit electronic or written comments on final guidance at any time. The FDA may consider those comments for future revisions. Submit electronic com­ments at http://www.regulations.gov/. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Ad­ministration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Identify comments with Docket No. FDA-2013-D-1445. The FDA also has instructions on how to submit confi­dential information. If those instructions are not followed, any submitted confidential in­formation will be made public.

Head Lice Infestation: Developing Drugs for Topical Treatment

In the October 6, 2016 Federal Register, the FDA announced the availability of the final guidance titled “Head Lice Infestation: De­veloping Drugs for Topical Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guid­ance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information will help sponsors plan clinical trials, design clini­cal protocols, and conduct and appropriately monitor clinical trials. This guidance makes final the draft guidance of the same name is­sued on December 15, 2015. No changes were made from the draft guidance. Interested parties may submit electronic or written com­ments as instructed above. Identify comments with Docket No. FDA-2015-D-4561.


The Regulatory Update is excerpted from Re­search Practitioner, Volume 17, Number 06, November-December 2016.

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