Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

by Hogan Lovells
Contact

Hogan Lovells

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. One of the most formidable is ensuring that their product and its updates comply with U.S. Food and Drug Administration (FDA) regulations, and that may mean navigating a lengthy clearance process. In 2017, however, the FDA introduced its Pre-Cert program, which is designed to fast-track clearance of a certified company’s current — and future — digital medical devices if the company proves it has the culture, capabilities, and transparency to meet the FDA’s quality and safety standards. Nine companies are participating in a Pre-Cert pilot, while the industry awaits the next phase.

In this hoganlovells.com interview, Kristin Zielinski Duggan, a Hogan Lovells counsel in Washington, D.C., discusses the FDA’s clearance process for digital medical devices and what companies can do to help streamline it. She also suggests that communications, software, and other companies seeking clearance for their devices start with one basic question: does my product fit the definition of an actively regulated digital medical device?

What common challenges do companies face related to compliance with FDA regulations and getting clearance of their digital medical devices?

Kristin Zielinski Duggan: The first thing that companies have to think about is whether they’re offering a medical device or not. There are so many mobile apps out there that are either not devices, or fall under what is called enforcement discretion, where the FDA is not actively regulating them. So the first question is always, am I an actively regulated device? There are guidance documents and policy statements constantly coming out — the 21st Century Cures Act made some changes — so it’s a moving target.

For things that are not medical devices, or that are carved out of active medical device regulation, companies don’t have to do a tremendous amount, from an FDA perspective. But companies that make something that fits the definition of a device and does not fit in any of these exceptions is going to be actively regulated by FDA. So if it’s intended to help prevent or treat or diagnose a disease, and it doesn’t fit in one of these categories, then FDA is going to want to know about it. 

If your product is a digital health care device, one of the challenges for a lot of companies is that they are actually telecommunications, Internet, technology, or software companies — not a traditional medical device manufacturer. So they essentially get turned into a medical device company, which comes with a tremendous amount of regulation and responsibility that you don’t have if you’re not a medical device company.

What mistakes do these companies often make when they have something that is a medical device but they’re not accustomed to the clearances and compliance process? 

Zielinski Duggan: One of the things we see all the time with software-type products is that, if you’re a medical device, you have to very tightly control the changes you make to your product. You have to assess each and every change for whether it requires additional FDA clearances. A lot of software companies struggle with or don’t fully understand that. They have software teams that are used to making tweaks on a daily or very regular basis to fix or make something better, and they don’t always realize what implications those types of things have from an FDA perspective. So they may not be actually controlling the changes in the way that FDA would expect them to. 

What are some of the ways in which we help clients understand these nuances?

Zielinski Duggan: With regard to making changes, that is one part of what is called the quality system, from an FDA perspective. It governs the entire process of what you should be doing  — from how your management is structured, to your standard operating procedures. There’s less manufacturing controls having to do with software, but there are controls you have to put in place for any suppliers that you have. Complying with the quality system is something that is really foreign to some companies, and again, assessing changes falls into one bucket of that. But, especially if a company is not a medical device company, the whole thing can be difficult. We frequently help clients assess the changes to their products to see whether they require additional clearances.

We also frequently help clients with the initial clearance. There are all sorts of different avenues to get a product on the market. Generally today they go through what’s called the 510(k) program and get cleared by FDA.

How do you help companies going through the FDA’s 510(k) program?

Zielinski Duggan: One big thing that our group does is help clients get medical devices approved or cleared. Companies that have a product that falls under an actively regulated device classification sometimes have to go through the 510(k) program, which means they have to get agency clearance before they can market their product. That’s a process that can take many months, which again is always a challenge for software companies, as they don’t understand why FDA can’t just move quickly like they do in terms of development and updating the software. We help them navigate that process. 

We probably do hundreds of 510(k)s a year and know all the different groups at FDA. There are different divisions and branches within those divisions that have different personalities and requirements in terms of testing. A digital health device is classified by therapeutic area — ob/gyn, cardiology, or whatever disease the device is related to. It could be within any of these groups at FDA; there’s not a particular group that reviews only digital health devices. We’re familiar with that process and what the agency is typically looking for.

The best way to navigate that process and get through it unscathed, as quickly as possible, and with a successful outcome, oftentimes involves going to meet with FDA beforehand to get an even better idea of what the agency wants. That can sometimes seem to companies like it would extend the process, but in fact it often results in a faster process, because once you file your marketing submission to FDA, it moves through a lot quicker. We help people with that process, called the pre-submission program, as well. 

The FDA developed a new Pre-Cert, or Precertification, program. How does it work?

Zielinski Duggan: As of now, digital health products that are determined to be actively regulated medical devices are going through the traditional pathways at FDA. There’s nothing all that different from that standpoint — you still have to prove exactly the same thing that you have to prove for a hardware type of medical device.

But FDA has rolled out what they’re calling the Precertification pilot program; it’s really more in an information-gathering stage now than a pilot. They’re trying to flip the way they do everything because of the digital health revolution and the fact that there are just so many digital products and apps, and they change so quickly, FDA just can’t keep up with them.  The FDA has admitted that it doesn’t work in the current regulatory framework. 

As an example, if somebody today had a digital health product that was a medical device that was cleared through the 510(k) process, and they make a change to it that would require a new 510(k), they may view that change like a software update that can be made in a day. But if that has to go back to FDA — that could be another three to six months before they can make the change. For companies that are working on software products, that’s just not feasible. 

So the FDA has put out this concept called the Pre-Cert program. What they’re planning on doing really flips the regulatory paradigm on its head: they’re essentially certifying a company as opposed to a product.

Currently, you submit an application for a product and they review it and clear that product. What they’re talking about doing is certifying a company as a quality company. There would be several levels of that; they’re envisioning two. Then that company would have either some sort of exemption or a streamlined process for their product in order to be able to market it. Essentially the idea is to say that your company is a quality company because the way that you develop and test your software has been determined to be up to a certain standard, and you’ll get a streamlined process for your new and upcoming products as a result. 

The companies in the pilot program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. FDA has stated they’ll be adding more. But it is not yet in the real pilot stage; right now, they’re mainly gathering information.

So it will be very interesting to see what happens with this. There are questions about whether Congress needs to give them additional regulatory authority or whether they can work within the existing framework. There are all kinds of questions about how to implement this program. FDA doesn’t know themselves. They’ve put out what they call working models — including lists of questions they want feedback on — and are soliciting advice. It’s a huge challenge, and so different from the way that they operate now that they’re really open to feedback from the industry or whoever can help them develop this innovative program. 

You’ve also mentioned another challenge for these companies, which may involve collecting massive amounts of data.

Zielinski Duggan: Yes, and this feeds into the Pre-Cert program. The FDA wants to collect real-world data on what’s happening with devices of all types. But as part of the Pre-Cert program, they want data to be collected from the connected digital health devices out there. It’s not exactly clear how it’s going to work; if a company has 25,000 people that have downloaded their app, how should they be monitoring data on all of those people and feeding that back into their quality system? There’s a question as to whether FDA wants all of that information or what they’re supposed to be doing with that.

But the idea that they should be monitoring devices out there has come up and the scope is not entirely defined. For other types of medical devices — say, a knee implant — if something bad happens, a doctor has to enter it in an FDA database or call somebody and say, this bad thing happened. Whereas with all these connected and digital health devices, the data is just feeding back to the company, so there will be some obligation to monitor what happens and somehow provide information to the FDA about that. Collecting that information might be a way to improve their product or systems or identify some sort of health problem. But how they will do that, especially on such a large scale, is yet to be determined. 

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Hogan Lovells | Attorney Advertising

Written by:

Hogan Lovells
Contact
more
less

Hogan Lovells on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.