Regulatory Update, May 2015
FDA draft guidance on premarket studies of implantable minimally invasive glaucoma surgical devices
The FDA has announced availability of a draft guidance for industry titled Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices. This leapfrog guidance document was developed to notify manufacturers of the recommended nonclinical and clinical studies to support a premarket approval application (PMA) for implantable MIGS devices. When made final, this draft guidance will recommend non-clinical and clinical studies support a PMA for implantable MIGS devices.
Glaucoma is a progressive condition that damages the optic nerve of the eye, is associated with elevated intraocular pressure and leads to irreversible vision loss. It is the second leading cause of visual disability and blindness in the world, with one in 40 adults over age 40 suffering from glaucoma having some visual loss. Current surgical treatments are aimed at reducing intraocular pressure (IOP). During the past decade, novel medical devices, called MIGS devices, have emerged, designed to treat less severe glaucoma by enhancing physiological aqueous outflow with an approach that causes minimal ocular trauma.
This draft is a leapfrog guidance; it is intended to serve as a mechanism through which the FDA can share initial thoughts regarding the content of premarket submissions for emerging technologies and new clinical applications likely to be of public health importance very early in product development, generally before the FDA has even received any such submissions. This guidance represents the FDA’s initial thinking.
To ensure the FDA considers your comments on this draft before it begins work on the final version, submit comments by May 12. Submit electronic comments to http://www. regulations.gov or written comments to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. It is only necessary to send one set of written comments. Identify comments with Docket No. FDA-2015-D-0288.
FDA guidance on developing drugs for complicated urinary tract infections
The FDA has announced availability of a guidance for industry titled Complicated Urinary Tract Infections: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). This guidance makes final the revised draft guidance of the same name issued Feb. 24, 2012.
This guidance includes recommendations for an efficacy endpoint and non-inferiority trial design. The efficacy endpoint, based on resolution of clinical symptoms and eradication of bacteria from the urinary tract, was derived from previously conducted clinical trials for the treatment of cUTI. The guidance provides a scientific justification for a non-inferiority margin based on historical observational data compared to the results of previously conducted clinical trials. After consideration of comments received in response to the draft, important clarifications about trial populations and endpoints for cUTI were included. In addition, this guidance reflects recent developments in scientific information that pertain to drugs being developed for the treatment of cUTI.
Interested persons may submit comments at any time, as instructed above. Identify comments with Docket No. FDA-2012-D-0148.
FDA draft guidance on evaluating drug effects on the ability to operate a motor vehicle
The FDA has announced availability of a draft guidance for industry titled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle. The purpose is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle.
Driving is a complex activity involving a wide range of cognitive, perceptual and motor activities. Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving is a public health priority. Drugs that impair driving ability also may impair the ability to judge the extent of one’s own impairment. This increases the need for objective evaluation of the presence and degree of driving impairment, with risk mitigation strategies based on that information.
This draft guidance recommends using a systematic effort to identify drugs for which evaluation of effects on driving abilities may be needed and the types of studies that such an evaluation entails.
Interested persons can comment on draft guidance at any time. Submit written or electronic comments on the draft as instructed above; identify comments with Docket No. FDA-2014-D-2300.
FDA guidance on medical device data systems, medical image storage devices and medical image communication devices; mobile medical applications
The FDA has announced availability of two guidance documents. FDA issued Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices to inform manufacturers, distributors and other entities that the FDA does not intend to enforce compliance with regulatory requirements for Medical Device Data Systems (MDDS) and two similar radiology device types due to the low risk they pose to patients and the importance they play in advancing digital health.
The FDA also issued an updated version of the guidance document Mobile Medical Applications, originally issued Sept. 25, 2013, that has been edited to be consistent with the MDDS guidance document.
The FDA recognizes the progression to digital health offers potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires many medical devices to be interoperable with various types of health information technology, including other types of medical devices. The foundation for such intercommunication is hardware and software that functions to transfer, store, convert formats or display medical device data without modifying the data or controlling the functions or parameters of any connected medical device.
The FDA issued a final rule Feb. 15, 2011, defining MDDS devices, medical image storage devices and medical image communications devices, reclassifying them from class III (high risk) to class I (low risk).
Since issuing that final rule, the FDA has gained additional experience with these types of technologies and has determined that these devices pose a low risk to the public. Therefore, in these documents, the FDA provides guidance on the compliance policy for MDDS devices, medical image storage devices and medical image communication devices, and makes conforming changes to the guidance document Mobile Medical Applications.
The FDA does not intend to enforce compliance with the regulatory requirements that apply to MDDS devices, medical image storage devices and medical image communications devices. The Mobile Medical Applications guidance has been updated to be consistent with the policy stated in the other guidance document. It also incorporates additional examples from the FDA’s mobile medical applications’ web site.
Interested persons may submit comments at any time, as instructed above. Identify comments on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices with Docket No. FDA-2014-D-0798. Identify comments on Mobile Medical Applications with Docket No. FDA-2011-D-0530.
FDA guidance on developing drugs for intra-abdominal infections
The FDA has announced availability of a guidance for industry titled, Complicated Intra- Abdominal Infections: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intraabdominal infections (cIAIs). Specifically, this guidance addresses the FDA’s current thinking regarding the overall drug development program, including clinical trial designs to support approval of drugs. This guidance makes final a draft guidance of the same name issued Oct. 1, 2012.
Intra-abdominal infections including cIAIs are common in clinical practice and comprise a wide variety of clinical presentations and differing sources of infection. Different bacterial pathogens are responsible for cIAI, including Gram-negative aerobic bacteria, Grampositive bacteria and anaerobic bacteria, including mixed infections. This guidance describes the efficacy endpoint of clinical success as resolution of the baseline signs and symptoms attributable to cIAI. The guidance provides a scientific justification for a non-inferiority margin. After consideration of comments received in response to the draft, the FDA updated the guidance to include clarifications about the primary efficacy endpoint and the use of prior non-trial antibacterial drugs.
Interested persons may submit electronic or written comments on final FDA guidance documents at any time, as instructed above. Identify comments with Docket No. FDA- 2012-D-0973.
Regulatory Update is excerpted from Research Practitioner, Volume 16, Number 2, March-April 2015.