Must-Know FDA Guidance Documents from 2017

FDA puts out a lot of information over the course of a year. Here’s what you absolutely need to know going into 2018.

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In 2017, FDA issued several new and updated guidance documents, furthering the agency’s mission to advance public health by helping to speed innovation, and bring more effective and safe medical devices to the marketplace. Here are the documents that are important for medical device manufacturers and industry to know.

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff

What FDA says: This revised guidance provides an overview on how manufacturers should engage with FDA regarding requests for agency feedback on issues relating to potential premarket applications and submissions. The document characterizes the feedback mechanisms and outlines information on the logistics for submission, receipt, tracking, and response to these requests.

Benefit: This guidance is a useful tool for obtaining FDA input on multiple pre-submission topics, including the regulatory path to market, the design of nonclinical, analytical and clinical testing, and submission review issues. The document addresses challenges that were not outlined in the previous version of the guidance, including an explanation of the agency’s expectations during the pre-submission process.

Challenge: Companies must keep current on FDA procedural changes and relate the new guidance to existing procedures. Properly timing pre-submission interactions and providing the necessary documentation to obtain needed input in the appropriate timeframe could also prove challenging.

Path Forward: Device makers should become familiar with the pre-submission program and learn to utilize these pre-submission engagements to streamline the premarket application/submission process. It can be beneficial to work with a partner who understands current FDA pre-submission program guidelines and the U.S. regulatory landscape.

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

What FDA says: This document defines interoperable devices and highlights design considerations in the development of electronic devices for manufacturers to prove reasonable assurance of a device’s ability to safely and effectively exchange and use exchanged information. It also outlines labeling considerations and explains the need to perform risk analysis, since creating connected systems of medical devices may introduce unforeseen safety and effectiveness issues.

Benefit: Creating systems of interoperable medical devices can improve efficiency and reduce cost. The recommendations outlined in this guidance regarding what information should be included in premarket submissions and device labeling provide insight into what the agency is expected to emphasize in its review of inoperable medical devices.

Challenge: Only recommendations for inoperable devices are addressed in this guidance, and no requirements are established. Additionally, the guidance does not focus on the physical compatibility of a device, or when a specific inoperable device or device modification would require a premarket submission.

Path Forward: Manufacturers should consider these recommendations throughout design, development, and submission preparation of inoperable devices.

Breakthrough Devices Program: Draft Guidance for Industry and FDA Staff

What FDA says: This guidance defines a breakthrough device and outlines how manufacturers can work with FDA on managing submissions for medical devices identified as such. This new voluntary program supersedes the agency’s existing programs, including the Expedited Access Pathway (EAP) and the Priority Review Program, while combining some aspects of the EAP and Innovation Pathway.

Benefit: This program will allow breakthrough devices priority attention, thereby expediting their assessment and review over other devices. The priority attention given to breakthrough devices will help patients have more timely access to these products.

Challenge: While breakthrough devices are granted priority review, they are not guaranteed a faster review when compared with standard review timelines. Breakthrough devices may take longer to review due to the potential scientific challenges FDA has historically encountered with novel products. Reviewers may have to invest time in understanding the mechanism of action and the appropriate evidence to demonstrate safety and effectiveness.

Path Forward: Manufacturers should review the breakthrough device designation criteria carefully to learn whether they may qualify for participation in the program. Designation is ultimately decided by the agency through the pre-submission process.

Classification of Products as Drugs and Devices and Additional Product Classification Issues (Final Guidance)

What FDA says: The guidance addresses issues pertaining to whether a product should be classified as a drug, device, biological product, or combination product. The document has two main sections: one outlines the request for designation process for obtaining a formal determination of a product’s classification and the other presents concepts for FDA’s decision-making process for classification.

Benefit: The guidance provides clarity on the process for product classification, which will enable informed planning for product development.

Challenge: While the guidance provides clarity for the process, determining the appropriate classification for a new product can be difficult.

Path Forward: Device companies should review the guidance in depth to become familiar with the process for classification and FDA definitions. Engaging a partner with experience in applying FDA’s classification process may make sense for situations in which the classification is not clear.

How to Prepare a Pre-Request for Designation (Draft Guidance)

What FDA says: This draft guidance describes how to obtain a preliminary assessment from FDA through the pre-request for designation (Pre-RFD) process. This process provides informal, non-binding feedback on the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product.

Benefit: FDA is enhancing the transparency and consistency of the process for receiving preliminary feedback on how a product will be regulated.

Challenge: While sponsors can request meetings with the agency either before or after submitting their Pre-RFD, the review time for their Pre-RFD may be extended. If a product is significantly changed during the Pre-RFD process, the feedback given by the agency may no longer be applicable and the need to submit a new pre-RFD should be assessed.

Path Forward: Manufacturers wishing to obtain a preliminary assessment from the agency should consider the recommendations outlined in the guidance.

Current Good Manufacturing Practice Requirements for Combination Products

What FDA says: The guidance defines a combination product and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products. The document clarifies the application of existing CGMP requirements and outlines how manufacturers can manage and report post-market safety data.

Benefit: Prior to this final rule, there were no regulations to define the application of CGMP requirements to combination products. These regulations establish a transparent and streamlined regulatory framework for manufacturers to use when demonstrating compliance with applicable CGMP requirements.

Challenge: The rules under this guidance still require interpretation.

Path Forward: FDA will expect that manufacturers comply with the regulation.

Qualification of Medical Device Development Tools

What FDA says: This guidance describes a voluntary program for qualifying medical device development tools (MDDT) used to evaluate the effectiveness, safety, or performance of a medical device and to support regulatory decision-making. The document defines the three categories of MDDT: clinical outcomes assessment, biomarker test, and non-clinical assessment model.

Benefit: This policy will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.

Challenge: The final guidance does not mention the review of tools submitted in individual premarket submissions for use with a specific medical device, nor does it address the expectations for the qualification of an individual MDDT submission.

Path Forward: Manufacturers should consider whether the tool(s) they are using for evaluating their medical device could be candidates for this program. The qualification process for the voluntary MDDT program should be carefully reviewed.

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

What FDA says: This document specifies expectations for reporting age, race, and ethnicity data for medical device clinical studies. It outlines recommendations for achieving enrollment and subgroup analyses.

Benefit: The document improves the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups.

Challenge: Obtaining the appropriate enrollment of diverse populations could prove difficult.

Path Forward: To achieve an unbiased estimate of treatment effect in the general population, manufacturers will need to develop a strategy to enroll diverse populations that is consistent with the intended use population of the device.

Cynthia Nolte, Sandra D. Maher, and Ashleigh Dawley

Cynthia Nolte, Sandra D. Maher, and Ashleigh Dawley

Cynthia Nolte, Ph.D., RAC, is director, regulatory affairs, medical device and diagnostic research at ICON plc.

Sandra D. Maher, M.S., RAC, is director, regulatory affairs, medical device and diagnostic research, at ICON plc.

Ashleigh Dawley is a regulatory affairs specialist, medical device and diagnostic research, at ICON plc.

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