United States: FDA: Examining Medical Device Provisions

The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices. The law also increases the number of diseases for which the humanitarian device exemption (HDE) may be applicable, aids sponsors of breakthrough devices by expediting the review process and alters FDA's authority to regulate certain types of medical software. Moreover, the device-related provisions enhance transparency with respect to FDA's decision whether to recognize international or national standards, and by giving industry representatives increased opportunities to participate in and influence device classification panel meetings. The legislation contains portions of several bills that were previously introduced, but not advanced by the Senate, including:

  • FDA Device Accountability Act of 2015,
  • Preventing Superbugs and Protecting Patients Act,
  • Advancing Breakthrough Devices for Patients Act of 2016,
  • Patient-Focused Impact Assessment Act of 2016, Combination Products Regulatory Fairness Act of 2016,
  • Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, and
  • FDA and NIH Workforce Authorities Modernization Act.

Overview of the Medical Device Provisions in the Cures Act

The device provisions are generally friendly to device manufacturers, with one notable exception—manufacturers of reusable devices. (Reusable devices came under scrutiny for their association with multi-drug resistant bacteria and a number of patient-to-patient infections linked to cleaning and reprocessing of the devices.) In general, the Cures Act provisions seek to:

  • Expedite the review process for breakthrough devices;
  • Extend the HDE to devices intended to treat a broader range of conditions;
  • Streamline the process for exempting certain devices from the premarket notification requirement;
  • Reduce burdens for manufacturers seeking Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived status for in vitro diagnostic (IVD) kits;
  • Clarify FDA's authority to regulate medical device software;
  • Clarify FDA's requirements for reusable devices, and position regarding when a 510(k) is required to be submitted for a modification to a device already on the market; and
  • Enhance transparency in a number of areas, including recognition of international standards and participation in device classification panels.

Why These Provisions Matter

CHANGES TO THE REVIEW AND APPROVAL OR CLEARANCE PROCESS

The expansion of FDA's existing priority review program for breakthrough devices for which there is no approved or cleared device currently on the market will benefit sponsors that receive a breakthrough designation. In addition to the potential benefits associated with the expedited review process, the new law provides that FDA may enter into a binding agreement with breakthrough device sponsors that addresses clinical protocols that could support an application for premarket approval or a 510(k) or de novo submission— and once the agency and a sponsor reach an agreement on trial design, FDA will encounter procedural hurdles if it decides to require changes to the protocol. Changes must be agreed to by both parties or FDA must meet with the sponsor to discuss a substantial scientific issue essential to determining the device's safety or effectiveness and issue a decision that such issue exists.

Manufacturers of devices that treat or diagnose conditions that affect 8,000 or fewer individuals in the US each year may benefit from the law's expansion of the HDE. Under the HDE, FDA may grant an exemption from effectiveness requirements for devices designed to treat or diagnose rare diseases for which no comparable device is available. The number of the devices distributed under a HDE must not exceed the number of devices reasonably needed to treat, diagnose or cure a population of not more than 8,000 individuals in the United States—prior to the Cures Act, the threshold was 4,000. Diseases that affect between 4,000 and 8,000 individuals in the US each year include tuberculosis and cerebral palsy, according to the National Organization for Rare Disorders. By increasing the potential populations that may be treated by a device available under an HDE, the Cures Act may increase utilization of the HDE pathway, which has historically been low. FDA's issuance of an accompanying guidance may help applicants provide information that will speed up the review process for HDEs, which has historically been lengthy.

Manufacturers of Class I and II devices may benefit from a provision that requires the agency to regularly re-evaluate whether such products should be subject to the 510(k) requirement. For those devices for which FDA decides not to require premarket notification, manufacturers will further benefit from a provision that streamlines the rulemaking requirement for making conforming revisions to applicable regulations. The procedures set forth in the Cures Act potentially expedite, by several years, the effective date of any FDA decision to not require premarket notification. As a result, the Cures Act appears to incorporate by statute the policy that FDA set forth in a 2015 guidance, which explained the agency would not enforce 510(k) requirements for Class I or II devices listed in the guidance, though FDA had not issued a final rule to amend its classification regulations.

REDUCED BURDENS

Sponsors of premarket approval applications may benefit from Congress's renewed emphasis that FDA consider the least burdensome means to meet agency needs when evaluating premarket submissions. Although the Cures Act does not change the standards for premarket approval, the law indicates FDA should consider the role of postmarket information when determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.

Manufacturers IVD kits are the beneficiaries of a provision that requires FDA to revise a specific section of an existing guidance on CLIA waiver applications. FDA has the authority to grant a test waived status under CLIA—and therefore make the test eligible for performance in a laboratory operating under a CLIA Certificate of Waiver—if the test is simple and has an insignificant risk of producing an erroneous result. FDA assesses whether a test has an insignificant risk of producing an erroneous result, in part, by evaluating whether the test produces accurate results when used by a waived user. Under the current version of the guidance, FDA evaluates accuracy by comparing the test's performance when used by a waived user to certain statistical guardrails that may or may not be clinically relevant based on the test's intended use. The Cures Act requires FDA to use a different, potentially less restrictive comparison when evaluating a test's accuracy—i.e., the test's performance when performed by a moderate complexity user. This change will likely require FDA to approve waiver applications for additional IVD kits.

FDA REGULATION OF SPECIFIC DEVICES

The Cures Act contains three provisions aimed at specific devices or accessories. First, manufacturers of certain reusable devices will be required to include validated instructions for use and validation data regarding the cleaning, disinfection and sterilization of such devices. Second, manufacturers of certain types of medical software may benefit from the enhanced regulatory clarity provided by a provision that explicitly excludes certain general software functions from FDA regulation. Third, manufacturers of accessories intended to be used with devices that require premarket approval or a 510(k) submission may benefit from the inclusion of an explicit statutory provision that allows FDA to down-classify accessories based on their intended use, as opposed to the classification of the device with which the accessory is intended to be used.

ENHANCED TRANSPARENCY

Manufacturers that comply with internationally recognized quality requirements may benefit from a new provision that sets forth enhanced procedures with respect to the recognition of such standards. Though the Cures Act does not change the existing process that enables FDA to recognize an international or national standard, the law requires the agency to be transparent in its rationale for recognizing, or declining to recognize, such standards. Under the new law, stakeholders may submit a request for the recognition of all or part of a standard created by an international or national standards organization. FDA must decide whether to recognize all or part of that standard and issue a publicly available rationale for the agency's determination. Although FDA may continue its non-recognition of well-recognized international standards (e.g., ISO 13485), requesters will be able to comprehend and possibly better respond to the agency's concerns once its rationale is made public.

The Cures Act will assist device industry representatives by providing enhanced transparency in the voting membership of device classification panels, which now must include individuals knowledgeable about technology and with clinically relevant expertise. The law does not change existing membership requirements or the types of organizations who may nominate individuals for the panels, but instead permits patients, patient representatives and device sponsors to recommend individuals with appropriate expertise for voting member positions. Industry representatives will be afforded additional opportunities during a panel meeting to correct misstatements, provide clarifying information and respond to questions from the panel.

What Is Required by These Cures Act Provisions

CHANGES TO THE REVIEW AND APPROVAL OR CLEARANCE PROCESS

Section 3051 of the Cures Act gives FDA explicit statutory authority to extend the existing priority review program for breakthrough devices to 510(k)s and de novo submissions. (Previously, in a guidance document, FDA extended the priority review program to 510(k) and de novo submissions due to the potential public health importance of devices warranting priority review status.) The Cures Act also codifies criteria for determining what constitutes a breakthrough device, and provides specific examples of significant, clinically meaningful advantages that reflect the guidance document. Section 3052, which expands eligibility for the HDE, requires FDA to issue a draft guidance defining a "probable benefit" to health from the use of the device. To obtain a HDE, the probable benefit to health must outweigh the risk of injury or illness.

Section 3054 requires FDA to identify and list any Class I or II devices that are exempt from the premarket notification requirement and update these lists at least every five years. FDA must publish initial lists of Class I and II devices in the Federal Register within 120 and 90 days, respectively, of the law's enactment. Previously, FDA was not statutorily required to update the list of Class II devices on a regular basis, or publish a list of Class I devices for which premarket notification is not necessary to assure safety and effectiveness, though the agency made a one-time commitment to identify 510(k) exempt devices during the last device user fee reauthorization.

REDUCED BURDENS

Section 3057 requires FDA to issue revised guidance on certain aspects of consideration for designation as a CLIA-waived IVD. Section 3058 instructs FDA to consider the least burdensome appropriate means necessary in requesting information related to premarket approval applications. The agency's summary of the scientific and regulatory rationale for significant decisions regarding submission or review of reports or applications must now include a statement on FDA's consideration and application of least burdensome requirements. Additionally, FDA employees involved in reviewing premarket submissions must receive training on the least burdensome requirements.

FDA REGULATION OF DEVICES, ACCESSORIES AND SOFTWARE

Section 3059 requires FDA to finalize a draft guidance describing when a manufacturer must submit a 510(k) for a modification or change to a device already on the market. Regulated industry has waited years for a revised guidance, as the current version dates to 1997 (and an earlier update was withdrawn in 2012). The Cures Act requires the agency to finalize the guidance by November 7, 2017.

Section 3060 carves out five types of medical software functions that will not be treated as devices: devices (1) for administrative support (i.e., claims); (2) for maintaining and encouraging a healthy lifestyle, but unrelated to the diagnosis, cure, prevention or treatment of a disease or condition; (3) that serve as electronic patient records if the records are part of certified health information technology; (4) for transferring, storing, converting or displaying clinical laboratory test or other data and results; and (5) for displaying, analyzing or printing medical information (other than medical images, signals from IVDs or signal acquisition systems), supporting or providing recommendations about prevention, diagnosis or treatment, if the health care professional may independently review the basis for the recommendations and is not intended to rely primarily on the recommendations to diagnose or treat patients. However, FDA may regulate some of the exempted software if the agency makes a finding that the software function would be reasonably likely to have serious adverse health consequences. To regulate exempted software, FDA must publish its finding, the agency's rationale, and a proposed order; accept comments; and publish a final order.

ENHANCED TRANSPARENCY

Section 3053 requires FDA to train its employees on the concept and use of recognized national or international standards for the purpose of meeting premarket submission or other requirements. FDA must also review and, if necessary, update existing or previously issued guidance and standard operating procedures that identify the principles for recognizing, or withdrawing recognition of, standards. Under existing law, FDA secures recommendations regarding the classification of devices into Class I, II or III from a panel of experts. Section 3055 adds a new membership requirement for the classification panels to ensure the panels have "adequate expertise," which the Cures Act defines as two or more voting members with a specialty or other expertise clinically relevant to the device under review and at least one voting member knowledgeable about the device's technology.

Action Steps For Device Manufacturers And Other Stakeholders

Sponsors interested in the breakthrough device pathway should begin to evaluate the extent to which existing data enables the sponsor to make a compelling argument under the criteria listed in Section 3051. If such data is lacking, sponsors should take steps to generate such data and arguments.

Device manufacturers should begin tracking the times when they believe FDA has required an unreasonable amount or type of information in order to support an application and consider invoking the new least burdensome review provision. Although FDA is not required to accept less data than is currently needed to support a submission, a sponsor of a device can use the language added by Section 3058 as leverage in negotiations with FDA over the amount and types of information required.

Finally, insofar as many of the above provisions require FDA to take steps to implement the changes envisioned by Congress, stakeholders should consider participating in public meetings or other outreach efforts by FDA to develop or revise applicable guidance documents.

FDA: Examining Medical Device Provisions

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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.