United States: FDA Devices Center Issues Multiple Guidances In The Obama Administration's Final Months

Last Updated: February 27 2017
Article by Michele Buenafe and M. Elizabeth Bierman

A flurry of regulatory activity preceded the transition in administration on January 20.

Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration's (FDA's or the Agency's) Center for Devices and Radiological Health (CDRH) issued more than a dozen draft and final guidances from December to January 19. These guidances address a wide range of topics, including investigational device exemptions, cybersecurity, combination products, postmarket surveillance, and medical product communications. An executive order issued by US President Donald Trump may impact the issuance of final versions of the draft guidances issued during this period as well as new guidances.

For those clients and friends who may not have kept up with CDRH's flurry of activity prior to January 20, this LawFlash provides brief summaries of those draft and final guidance documents issued during this period that have broad applicability. We have not included device-specific guidance documents.

Final Guidances

Public Notification of Emerging Postmarket Medical Device Signals

This final guidance, issued December 14, 2016, establishes a process for issuing notifications to the public on new and evolving benefit-risk information (referred to as "emerging signals") about medical devices. As described in our December 21 LawFlash, this final guidance includes several changes to address concerns that emerging signals notifications would be issued based on unreliable or unconfirmed information.

Postmarket Management of Cybersecurity in Medical Devices

As described in a prior LawFlash, FDA issued this final guidance on December 28, 2016 to advise device manufacturers on the applicability of FDA's medical device correction and removal reporting requirements to devices with known cybersecurity vulnerabilities, and to recommend that manufacturers define and document processes for assessing cybersecurity risks for their devices.

Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types

On December 30, 2016, FDA issued its final guidance for medical device accessories. This guidance defines "accessory," describes FDA's policy on classification of accessories, and encourages manufacturers to use the de novo classification process to request classification of new types of accessories. This final guidance includes changes to address concerns that the proposed guidance could blur the line between device components (which are not subject to direct FDA oversight) and device accessories. In addition, this final guidance reflects the new statutory requirements for accessory classifications that were included in the recently enacted 21st Century Cures Act (Pub. L. 114-255).

Current Good Manufacturing Practice Requirements for Combination Products

This final guidance, issued January 11, 2017, describes and explains FDA's January 22, 2013 final rule on current good manufacturing practice (CGMP) requirements for combination products (21 C.F.R. Part 4). The final rule is intended to clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products, and to streamline the regulatory framework for manufacturers of such products. This guidance provides further information on the purpose and content of specific CGMP requirements included in the final rule, and includes hypothetical scenarios to help explain how to comply with CGMP requirements for specific types of combination products.

Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions

FDA issued this final guidance on January 13, 2017 to clarify for clinical study sponsors and sponsor-investigators what factors FDA considers when assessing the risks and anticipated benefits of investigational device exemption (IDE) applications for clinical studies. This guidance further discusses how risk mitigation measures can help ensure appropriate protections for study subjects. Notably, FDA states that the total product life cycle of the device will be considered, and it expects a greater amount of uncertainty at earlier stages of device development. Additionally, FDA will consider the contextual setting in which the study is being proposed, including the disease or condition being treated or diagnosed, the availability of and risks associated with alternative treatments or diagnostics, and any information regarding the subjects' tolerance for risk and perspective on the benefit.

Emergency Use Authorization of Medical Products and Related Authorities

FDA's Office of Counterterrorism and Emerging Threats prepared this final guidance, which issued January 13, 2017, to explain FDA's procedures for authorizing the emergency use of certain medical products. These procedures are intended to implement certain laws that support national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. Medical devices that may be required in such situations include in vitro diagnostics and personal protective equipment.

Draft Guidances

How to Prepare a Pre-Request for Designation (Pre-RFD)

This draft guidance, issued January 13, 2017, describes a proposed new process to obtain informal, nonbinding feedback on FDA's determination of whether a product will be considered a combination product or a drug, device, or biological product. FDA states that this draft guidance is intended to make transparent the process that its Office of Combination Products has been following, and is in response to requests from sponsors. Unlike the formal request for designation process, the pre-RFD need not include detailed manufacturing information, supportive data/studies, or an analysis of the classification or primary mode of action. Additionally, there is no user fee for a pre-RFD. Comments on this draft guidance should be submitted by April 13, 2017 in order to be considered before FDA begins work on the final guidance.

Medical Product Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers

FDA announced this draft guidance, which discusses one of the most controversial (and much litigated) areas of FDA regulation, on the last day of the Obama administration, January 19, 2017. This draft guidance, which applies to drugs and biological products as well as devices, describes how FDA evaluates firms' medical product communications that present information not specifically contained in the FDA-required labeling, but that is consistent with such labeling. Additionally, it provides recommendations on how to convey such "consistent" information in a way that is truthful and not misleading. FDA requests that comments on this draft guidance be submitted by April 19, 2017.

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers

FDA also issued this draft guidance on January 19, 2017, contemporaneously with the above-referenced guidance on medical product communications. This draft guidance addresses dissemination of information about investigational devices to payors before FDA approval or clearance of such products. It also addresses communications for drugs and biological products, including communications related to healthcare economic information per Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)), which was recently modified and expanded under the 21st Century Cures Act. This draft guidance is intended to provide further clarity to firms and payors regarding when dissemination of healthcare economic information will not be considered false or misleading. FDA is accepting comments on this draft guidance until April 19, 2017.

This article is provided as a general informational service and it should not be construed as imparting legal advice on any specific matter.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.