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FDA Draft Guidances Released for Medical Device and Diagnostic Areas

Friday, July 29, 2016   (0 Comments)
Posted by: Stephen Rapundalo
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The Food and Drug Administration (FDA) issued a series of draft guidances over the last few weeks in various product areas. The proposed guidelines are now open for a 90-day public comment period (see below for instructions on how to submit comments or suggestions to the agency).



Medical Devices - Unique Device Identification.

FDA just released a new draft guidance, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI),” to help define the expected content and forms of the Unique Device Identifier (UDI), and assist both manufacturers and FDA-accredited issuing agencies (IA) in ensuring that UDIs are in compliance with the UDI Rule.


The draft guidance proposes that UDIs be formatted on a device's label in two ways: 1) in an "easily readable plain-text form", and 2) in a form that uses automatic identification and data capture technology, such as a barcode, that can be automatically entered into an individual's EHR or other computer systems. Moreover, the guidelines speak to how UDI information should be ordered, their placement or location, and how they appear relative to non-UDI information. It further clarifies that UDIs are only required to contain information about a device’s unique identifier.


The draft guidance comes less than two months before the UDI compliance date for Class II devices. It raises many questions and implies that perhaps UDI’s already issued by IAs may not be in compliance with labeling requirements. In addition, several new concepts are introduced that have not been broached previously in the rule or in guidance since the rule was finalized. It’s unclear how FDA will respond with enforcement for those who’ve acted in good faith but inadvertently are deemed to be in compliance to the proposed provisions.



Medical Devices – Adaptive Design.

A draft FDA guidance, “Adaptive Designs for Medical Device Clinical Studies,” provides sponsors and agency staff with guidelines on how to plan and implement adaptive designs for clinical studies in the course of medical device product development.


The agency indicated that it had essentially incorporated most of the over 150 public comments received from groups like AdvaMed and companies.


The new guidance provides examples of how to properly incorporate adaptive designs into clinical trials. It speaks to various aspects of adaptive design use – namely, what adaptive designs are, when to choose one, how to decide if a particular design will be advantageous, use and application of unblinded data, and others. Also, the guidance points to the resulting benefits of appropriate adaptive design including efficiency and cost effectiveness, better understanding of device benefits and risks, and stronger transitions from pre-market analysis to post-market follow-up.


The guidance document applies to premarket medical device submissions, including premarket approval (PMA) applications, premarket notification (510(k)) submissions, de novo submissions (evaluation of automatic class III designation), humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) submissions. The principles contained in the guidance can be applied throughout a device’s clinical development program, from feasibility studies to clinical trials.



Medical Devices – Real-World Evidence.

A draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” was issued to help clarify on the circumstances under which real-world data (RWD) may be used to support premarket and postmarket regulatory decisions for medical devices.

In the guidance, FDA describes key factors it will use to assess the relevance and reliability of real-world data.


Furthermore, it clarifies when an investigational device exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. 

FDA believes that real-world data generated in the course of routine clinical care and patient management can potentially meet regulatory standards and reduce the burdens of obtaining appropriate evidence across the life cycle of a device.


The agency previously indicated that RWE will be a critical source of information under a National Evaluation System for Medical Devices, which is still under development.



Diagnostics – Next-Generation Sequencing.

FDA has issued two long-awaited draft guidances on next generation sequencing (NGS) diagnostic tests.  The first, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases,” provides recommendations for designing, developing, and validating NGS in vitro diagnostics (IVDs) and discusses the use of standards as part of the regulatory controls.  A second, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics,” describes the use of publicly available databases to identify scientific evidence that can support the clinical validity of an NGS IVD.


"The FDA values the input we received from genomics experts, industry, health care providers and patients from four public workshops and other outreach opportunities. Based on this input, we crafted draft recommendations that we believe will encourage innovation and advance the goal of precision medicine: to speed the right individualized treatments to patients sooner," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Precision care is only as good as the tests that guide diagnosis and treatment. The FDA's job is to ensure that doctors and patients can depend upon the accuracy, reliability and clinical validity of these tests. It's our hope that this approach will achieve just that."


This adaptive approach to regulating NGS-based tests is part of the FDA's engagement in the Precision Medicine Initiative (PMI) launched by the White House in early 2015. The hope is the draft guidelines, when finalized, will provide a more efficient and flexible approach to the oversight of genetic tests and testing.


"Targeting the right treatments to the right patients at the right time is the goal of the President's Precision Medicine Initiative," said FDA Commissioner Robert Califf, M.D. "Soon, patients will have a much more complete picture of their health than in the past, informed by their genetic and genomic makeup. The FDA is preparing for this exciting approach at multiple levels."

The FDA encourages public comments on the draft guidances during a 90-day comment period. Comments and suggestions should be submitted electronically to Submit written comments to the Division of Dockets Management (HFA-35), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should identify the docket number listed in the notice of availability that publishes in the Federal Register.

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