Regulatory Update, June 2015
FDA draft guidance on acceptance of medical device clinical data from studies conducted outside the U.S.
The FDA has announced availability of a draft guidance titled Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff. This draft guidance articulates the FDA’s current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices.
The guidance describes special considerations that apply when using such data, including applicability to populations within the U.S. and study design issues and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards to support approval or clearance of the device in the U.S. This guidance is not intended to announce new policy, but to describe FDA’s existing approach to this topic.
In July 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), adding a new provision to the Federal Food, Drug, and Cosmetic Act codifying FDA’s longstanding policy of accepting adequate, ethically-derived, scientifically valid data without regard to where a clinical study is conducted. Sponsors may choose to conduct multinational clinical studies under a variety of scenarios. The FDA acknowledges, however, that certain challenges exist in using data derived from studies of devices from sites outside the U.S. (OUS) to support an FDA marketing decision.
These challenges may include differences between OUS and U.S. clinical conditions, regulatory requirements (including human subject protections) and/or study populations that may be sufficient to affect the adequacy of the data for use in establishing the safety and/or effectiveness of the studied device. This guidance focuses on considerations sponsors of device submissions should take into account when initiating, or relying on previously collected data from, an OUS clinical study to support an Investigational Device Exemption (IDE) application or any relevant marketing application.
The guidance also notes other important considerations to take into account when initiating or relying on OUS data. The FDA believes promoting greater clarity concerning the FDA’s use of foreign study data will minimize the possibility for additional or duplicative U.S. studies and will further efforts to harmonize global clinical trial standards and promote public health and innovation.
The FDA requests comments on this draft be submitted by July 20, 2015. However, interested persons can comment on draft guidance at any time, and the FDA will accept those comments, although it may not consider them until a future date when this document is being revised. Submit electronic comments to 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-0975.
FDA recommends using WHO drug dictionary
The FDA has announced its support for the World Health Organization (WHO) Drug Dictionary (available at www.who-umc.org/), maintained and updated by the Uppsala Monitoring Center. The FDA encourages sponsors and applicants to use WHO Drug Dictionary codes in investigational study data provided in regulatory submissions for drug and biological products.
The WHO Drug Dictionary contains unique codes for identifying drug names and evaluating medicinal product information, including active ingredients and therapeutic uses. Typically, the WHO Drug Dictionary is used to code concomitant medications used by subjects during the course of a clinical trial. The WHO Drug Dictionary will be listed in the FDA Data Standards Catalog posted to the FDA’s Study Data Standards Resources website at www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
The use of a common dictionary to code concomitant medications is an important component of study data standardization. The analysis of study data is greatly facilitated by the use of controlled terms for clinical or scientific concepts that have standard, predefined meanings and representations. The FDA encourages sponsors and applicants to provide WHO Drug Dictionary codes for concomitant medication data in investigational studies provided in regulatory submissions. The codes should include the drug product trade name where available, the active ingredient(s) and the Anatomical Therapeutic Chemical class.
Reprocessing medical devices in healthcare settings: Validation methods and labeling
The FDA announced availability of a guidance titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. This final guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. It also provides recommendations for the content and review procedures for all relevant marketing applications and Investigational Device Exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. This guidance reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices, especially more complex, reusable medical device designs that are more difficult to reprocess.
In recent years, there has been a significant advance in knowledge and technology involved in reprocessing reusable medical devices. Additionally, there has been an evolution toward more complex medical device designs that are more difficult to clean, disinfect and sterilize. This guidance reflects the scientific advances in these areas. Under FDA law and regulation, a device must have adequate directions for use, which include instructions on preparing a device for use. Instructions on how to reprocess (i.e., clean, disinfect and sterilize) a reusable device are critical to ensure the device is appropriately prepared for its next use.
The FDA published the draft of this document in May 2011 and held a public workshop titled Reprocessing of Reusable Medical Devices Workshop, the purpose of which was to discuss factors affecting the reprocessing of reusable medical devices and the FDA’s plans to address the identified issues. The discussion during this workshop and the comments on the draft were considered before revising the guidance. This final guidance supersedes Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, dated April 1996.
This final guidance contains the addition of Appendix E: Devices for which a 510(k) Should Contain Data to Validate Reprocessing Instructions, which includes a subset of medical devices the FDA has identified that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed. Because of this greater public health risk, marketing submissions for these devices should include protocols and complete test reports of the validation of the reprocessing instructions.
Interested persons may submit electronic or written comments on final FDA guidance documents at any time. Submit comments as instructed above; identify comments with Docket No. FDA-2011-D-0293.
FDA draft guidance on electronic Informed Consent
The FDA has announced availability of a draft guidance for industry, clinical investigators and institutional review boards (IRBs) titled Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers. The draft guidance provides recommendations for clinical investigators, sponsors and IRBs on the use of electronic media and processes to obtain Informed Consent for FDA-regulated clinical investigations of medical products including drugs, biological products, medical devices and combinations thereof.
In particular, the guidance provides recommendations on procedures that may be followed when using an electronic Informed Consent (eIC) to help (1) ensure protection of the rights, safety and welfare of human subjects; (2) ensure the subject’s comprehension of the information presented during the eIC process; (3) ensure appropriate documentation of consent is obtained when electronic media and processes are used to obtain Informed Consent; and (4) ensure the quality and integrity of eIC data included in FDA application submissions or made available to the FDA during inspections.
To enhance human subject protection and reduce regulatory burden, DHHS’s Office for Human Research Protections (OHRP) and the FDA have been working to harmonize their respective regulatory requirements and guidance for human subject research. This guidance document was developed as part of these efforts.
Interested persons can comment on draft guidance at any time, and the FDA will accept those comments, although it may not consider them until a future date when this document is being revised. Submit comments as instructed above; identify them with Docket No. FDA-2015-D-0390.
The Regulatory Update is excerpted from Research Practitioner, Volume 16, Number 3, May-June 2015.