United States: 21st Century Cures Act And Medical Device Regulatory Pathways

Last Updated: December 15 2016
Article by Michele Buenafe and M. Elizabeth Bierman

These seven key provisions will affect the premarket requirements for medical devices.

The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law. Included in the legislation are several provisions that affect medical device premarket pathways and the US Food and Drug Administration's (FDA's or the Agency's) obligations related to device premarket issues.

We have summarized below the seven key provisions that will affect the premarket requirements for medical devices.

Breakthrough Devices (Section 3051)

The legislation establishes a program to expedite the development of devices considered "breakthrough" technologies. This new program builds on the existing Expedited Access Pathway (EAP) program, as described in FDA's April 2015 guidance document.

Breakthrough technologies include devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions and devices that meet unmet needs. The new program is open to devices proceeding through the 510(k) pathway, as well as the premarket approval and de novo pathways. The benefits of designation as a "breakthrough" device include assignment of a specific team of FDA staff; interactive and timely communication with FDA during the development and review process; expedited review of manufacturing and quality systems compliance, as applicable; and a process for written agreement to clinical protocols that will be binding on FDA and sponsor.

In its first year, the existing EAP program accepted 17 devices. By adding 510(k) devices, the legislation provides for a larger pool of potentially eligible devices. As with the EAP program, the new program under this legislation does not include any timelines for review of submissions for breakthrough devices.

Humanitarian Device Exemptions (Section 3052)

This provision will expand the availability of the humanitarian device exemption (HDE). Currently, to obtain an HDE, a sponsor must pursue an indication for a device intended to treat a disease that affects no more than 4,000 people. This is a significant difference from the orphan drug development program, which has a disease ceiling of 200,000 people. Some have expressed concerns that the HDE ceiling has significantly limited the effect of this program; only 10 HDEs were approved in 2014 and 2015. To address this issue, the statute will increase the HDE ceiling to 8,000 people.

Recognition of Standards (Section 3053)

The legislation provides that any person may submit a request for recognition of all or part of an appropriate standard established by a nationally or internationally recognized standard organization, and requires FDA to make a determination on recognition of the standards within 60 days. FDA is required to issue guidance on the principles for recognizing standards. Significantly, to help ensure that standards can be used effectively to meet premarket submission data requirements, the legislation requires FDA to provide training to its employees who review device premarket submissions on the concept and use of recognized standards to meet premarket submission requirements.

510(k) Exemption Process for Class I and II Devices (Section 3054)

This provision requires FDA to publish in the Federal Register lists of Class I and II devices (by product code) that no longer require 510(k) clearance every five years and to implement the exemptions. The first such lists of Class I and II devices must be published no more than 90 days (for Class II devices) and 120 days (for Class I devices) after the legislation's enactment. In August 2015, FDA published a guidance that included a list of more than 100 Class I, Class II, and unclassified device types for which the Agency did not intend to require 510(k)s. These exemptions have not been promulgated in rulemaking, but presumably would be included in the first lists published after the legislation is enacted.

Classification Advisory Committee Meeting (Section 3055)

This provision is intended to ensure that an FDA advisory panel considering device classification has the appropriate clinical and/or technological expertise with respect to the relevant device types. The new law requires that FDA allow sponsors, patients, and patients' representatives to provide recommendations for persons with the appropriate expertise to fill the positions on the panels.

Least Burdensome Requirements (Section 3058)

Section 513 of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997, currently provides that FDA shall consider the "least burdensome" means of evaluating device effectiveness or substantial equivalence for devices that are the subject of premarket approval applications or 510(k) premarket notifications. In 2002, FDA published guidance, The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles, describing the circumstances when nonclinical data or clinical data from novel study designs potentially could be used to shorten the time required to generate data to support approval or clearance.

Because the existing statutory requirement and guidance have not resulted in consistent or meaningful application of least burdensome principles, the new legislation requires that FDA provide training for its employees on the "meaning and implementation of the least burdensome requirements," conduct an audit of the training, and perform periodic assessments of the implementation of the least burdensome requirements. Additionally, the new provisions require that FDA consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of safety and effectiveness.

Combination Products Innovation (Section 3038)

These provisions are intended to address concerns about the complexity and length of the combination product review process and to clarify the criteria for FDA's drug versus device classification decisions. The Office of Combination Products (OCP) has been criticized for over classifying products as drugs, even in cases where there was long-standing FDA precedent for the classification and regulation of the products in question as devices. These issues were brought to the forefront during the litigation brought by a French company, Prevor, against FDA regarding its skin wash product. In this case, the parties litigated for more than two years the issue of whether Prevor's product had a drug primary mode of action due to its "chemical action" on the human body, with FDA taking the position that any chemical action rendered the product a drug, regardless of whether the primary mode of action was principally achieved by other means (e.g., via physical action).

The legislation states that FDA shall not determine that a combination product's primary mode of action is that of a drug or biological product solely because the product has any chemical action within or on the human body. In addition, the new law provides that the sponsor may propose one or more studies to establish the relevance of the chemical action in achieving the primary mode of action.

To help streamline the combination product review process, the new provisions allow FDA to take into account prior findings of safety and effectiveness of a combination product's approved or cleared constituent parts. The legislation also sets forth a dispute resolution process when two product centers do not agree and establishes procedures for OCP intended to ensure timely and efficient review of combination products. Finally, the legislation states that, no later than 18 months after enactment, FDA shall identify types of combination products and manufacturing processes for which good manufacturing processes may vary from those set forth in FDA regulations.

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.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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.