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FDA Uses Summer to Issue Numerous Device Guidance Documents

The Agency shows no signs of slowing regulatory activity.

Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it appears to have stepped up its guidance development activity even more this summer. During June and July, CDRH issued 15 draft and final guidance documents addressing a wide variety of both premarket and postmarket issues, including general wellness devices, next-generation sequencing in vitro diagnostic devices, companion diagnostics, categorization of investigational device exemptions (IDEs) for reimbursement purposes, adaptive designs for clinical studies, and benefit-risk analyses affecting compliance and enforcement decisions.

To help update those clients and friends who may have not have kept up with CDRH’s fast-paced issuance of guidance documents this summer, we have provided below brief summaries of draft and final guidance documents issued in the June to July 2016 time period.

General Wellness: Policy for Low Risk Devices

This Final Guidance, issued on July 29, establishes FDA’s compliance policy for low-risk devices intended to promote a healthy lifestyle. FDA does not intend to actively regulate products that are both intended for general wellness purposes (e.g., weight management, physical fitness, and sleep management) and are low risk, as those criteria are defined in the Final Guidance. This means the products that meet these criteria will not be subject to any premarket submission requirements or to any other device regulatory requirements, including registration, listing, labeling, quality system, or reporting requirements. To read more about this Final Guidance document, see  FDA Issues Final Guidance For General Wellness Devices.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

FDA issued this Draft Guidance on July 27 to recognize the valuable data on medical device experiences that are routinely collected from sources outside of traditional clinical trials. The Draft Guidance describes various circumstances under which real-world evidence may be used in different FDA contexts. These include to generate hypotheses to be tested in a prospective clinical study, as a historical control, for public health surveillance efforts, and for post-approval studies.

Adaptive Designs for Medical Device Clinical Studies

An adaptive design study is a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining a study’s integrity and validity. This Final Guidance, which issued on July 27, addresses issues related to the use of adaptive designs in device clinical studies intended to support a marketing submission. Among these issues are when to choose an adaptive design, advantages and limitations of adaptive designs, how to control the chance of erroneous conclusions and minimize operational bias, various types of adaptive designs, and regulatory considerations.

Unique Device Identification System: Form and Content of the Unique Device Identifier

FDA issued yet another Draft Guidance on unique device identifiers (UDIs) on July 26 as it continues the march toward UDI implementation. The Draft Guidance sets forth a UDI’s expected content and forms to ensure that UDIs comply with the UDI regulation at 21 C.F.R. § 801.40.

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product

An in vitro diagnostic (IVD) companion device is an IVD that provides information required for the safe and effective use of a corresponding therapeutic product. In most cases, FDA’s market authorization for the two products should occur contemporaneously. The Draft Guidance, which issued on July 15, is intended to provide practical advice to assist both the sponsor of an IVD and the sponsor of a therapeutic product in the product development and review process. This includes advice relating to IVD validation requirements, therapeutic product clinical trial design issues, labeling, coordinating review timelines, and post-marketing considerations.

Information to Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Devices

This Final Guidance, issued on July 11, describes the information that should be included in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device.

Use of Standards in FDA Regulatory Oversight of NGS-Based IVDs Used for Diagnosing Germline Diseases

As we discussed in our prior LawFlash, FDA Issues Draft Guidance As Part of Precision Medicine Initiative, this Draft Guidance document and the one below  issued on July 8 to address next generation sequencing (NGS)–related issues that may affect both test developers and genetic database administrators. The above-titled Draft Guidance describes the use of standards and the FDA’s de novo classification mechanism to develop a potential pathway to market for NGS-based tests for germline diseases.

Use of Public Human Genetic Variant Databases to Support Clinical Validity for NGS-Based IVDs

This Draft Guidance, which issued on July 8 along with the guidance discussed immediately above, describes how publicly accessible databases of human genetic variants can be a source of valid scientific evidence to support the validity of NGS-based tests.

Procedures for Evaluating Appearance Issues and Granting Authorization for Participation in FDA Advisory Committees

This Draft Guidance, issued on June 27, discusses FDA’s process for evaluating whether an advisory committee member has interests or relationships that do not require recusal but present an appearance of a lack of impartiality.

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

This Final Guidance, issued on June 21, aims to increase the availability of safe and effective pediatric devices by clarifying the specific criteria that FDA applies in deciding whether leveraging existing clinical data to support pediatric claims is appropriate, and if so, to what extent. Understanding the challenges associated with conducting pediatric clinical trials, the Final Guidance describes and provides examples from a complex “decision tree” to aid in identifying the appropriate scope of extrapolations, associated benefits, and potential pitfalls to avoid or address.

Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

This Draft Guidance document, issued on June 20, outlines the FDA’s expectations and recommendations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies that support a marketing submission. In issuing the Draft Guidance, FDA intends to encourage collection and consideration (during the study design stage) of relevant age, race, ethnicity, and associated covariates for devices for which safety, effectiveness, or benefit-risk profile is expected to vary across these groups.

Use of International Standard ISO 10993—Biological Evaluation of Medical Devices, Part 1

This Final Guidance, issued on June 16, addresses biocompatibility testing required for medical devices that are the subject of a premarket submission and come into direct or indirect contact with the human body. As of September 14, 2016, the Final Guidance will supersede the FDA’s 1995 guidance on use of International Standard ISO 10993 for biocompatibility testing. The Final Guidance incorporates updates to ISO 10993 and describes use of risk-based approaches to determine if biocompatibility testing is needed.

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

One of FDA’s missions is to limit the availability of violative medical devices and to pursue compliance and enforcement actions related to violative products. FDA recognizes, however, that decisions regarding potential compliance and enforcement actions are fact-specific and should include consideration of the potential effect on patients. This Draft Guidance, issued on June 16, discusses the benefit and risk factors that FDA may consider in prioritizing the Agency’s resources for compliance and enforcement efforts.

Dissemination of Patient-Specific Information from Devices

This Draft Guidance, issued on June 10, is intended to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. In particular, the Draft Guidance is intended to clarify that FDA regulations and guidance do not prohibit device manufacturers from sharing such information with patients and that sharing this information with patients does not require additional premarket review. Refer to  FDA Clarifies Policy for Sharing Patient-Specific Data from Devices, for additional information on this guidance.

FDA Categorization of IDE Devices to Assist CMS with Coverage Decisions

This Draft Guidance, issued on June 1, is intended to provide information on the FDA’s categorization of investigational devices, to help support coverage (i.e., reimbursement) decisions by the Centers for Medicare & Medicaid Services (CMS). Although certain devices with an approved IDE may be covered under Medicare, over the years, FDA has received a number of IDEs that do not fit into the previously established categorization framework. Therefore, CMS and FDA are revising their shared understanding regarding the categorization of IDE devices to help ensure that devices will not be precluded from reimbursement because of an inappropriate reimbursement categorization determination.

Copyright © 2023 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VI, Number 244

About this Author

Elizabeth Bierman, Regulatory and compliance lawyer, Morgan Lewis
Senior Counsel

M. Elizabeth Bierman represents US and international companies in US Food and Drug Administration (FDA) and state regulatory matters that impact the development, manufacturing, and marketing of their products. Beth has more 25 years of experience representing companies that produce a range of products regulated by the FDA, including medical devices, digital health products and mobile medical applications, tissue products, combination products, pharmaceuticals, medical foods, and infant formulas. She also provides guidance on related jurisdictional issues and regulatory...

Michele L. Buenafe, Morgan Lewis, Regulatory and Compliance Attorney

Michele L. Buenafe advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling, and advertising of medical devices, human tissue products, pharmaceuticals, controlled substances, listed chemicals, and combination products. She also advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, telemedicine systems, wearable devices, and other health information technology. Michele also serves as a co-leader for the firm’s...