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Regulatory Update, June 2015

Monday, June 1, 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FDA draft guidance on acceptance of medical device clinical data from studies conducted outside the U.S.

The FDA has announced availability of a draft guidance titled Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff. This draft guidance articulates the FDA’s current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions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.

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