Mid-Year FDA Regulation & Guidance Review

Introduction
It is often difficult to stay abreast of the many regulatory changes occurring within the medical device industry, not to mention what they may mean in practice for global manufacturers. To assist with this mission, provided below is a mid-year review of noteworthy U.S. Food & Drug Administration (FDA) regulatory updates and guidance releases thus far throughout 2018.

FDA Guidance*
To date, the FDA has released several guidance documents pertaining to medical devices and combination products. Listed below is a summary of select FDA guidance documents published in 2018 for medical devices and combination products. Many of these were issued in response to the 21^st Century Cures Act, which is “designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.”

*Simply click on the Guidance titles below to be linked directly to the guidance document.

In addition to the below information, the FDA’s website serves as a valuable resource for draft and final guidance documents that the regulatory agency intends to publish for the remainder of Fiscal Year 2018. Also included is a list of older guidance documents that are intended to undergo retrospective reviews to determine future updates.

FDA RESOURCES

I. Webinars

The FDA frequently hosts online webinars that are complimentary to the public. The purpose of these events is to review new guidance and policy documents, or to discuss other scientific topics of interest to the medical device community. Not only do attendees have the opportunity to directly ask webinar presenters questions at the close of each online event, but these webinars are available on-demand should you be unable to attend the live event. Accessing these materials is often a good way to keep updated on the FDA’s current thinking on proposed or newly implemented guidance documents and specific areas of medical device development.

Below is a summary of archived webinars held in 2018, which include presentation slides and transcripts. Click on the links below for more information and/or archived webinar materials for each topic. A full list of medical device webinars for 2018 as well as archived webinars from 2016 and 2017 can be found on FDA’s website.

• January 10, 2018: Technical Considerations for Additive Manufactured Medical Devices
  • See NAMSA’s blog post on this topic here
• February 27, 2018: Custom Device Annual Reporting
• April 30, 2018: Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices
• May 10, 2018: User Session – Digital Health Software Precertification (Pre-Cert) Pilot Program

II. Public Workshops and Meetings
A full list of public workshops and meetings for 2018, as well as archives for years 2014-2017, can be found on FDA’s website. Listed below are upcoming workshops that may be of interest to U.S. medical device manufacturers.

• August 13-14, 2018: Public Meeting – Pediatric Medical Device Development
  Location: FDA White Oak Campus (Silver Spring, MD)
• September 12, 2018: Public Workshop – Patient Engagement in the National Evaluation System for health Technology (NEST): Lessons Learned and Best Practices Workshop Announcement
  Location: University of Maryland (Baltimore, MD)
• May 22-23- 2018: Public Workshop – Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards
• May 9-10, 2018: 11th Annual ​FDA-AdvaMed ​Medical ​Devices ​and ​Diagnostics ​Statistics ​Conference

• April 30, 2018: Public Workshop – Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices
• April 16, 2018:  Public Workshop – Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults
• January 30-31, 2018: Public Workshop – Fostering Digital Health Innovation: Developing the Software Precertification Program

III. Online Learning Portal
If you’re new to the medical device field, per perhaps just wish to obtain a clearer understanding of the FDA’s regulatory requirements, a valuable resource is FDA’s online learning portal called the Center for Devices and Radiological Health (CDHR) Learn. Modules are available in the most relevant areas of medical devices in English, with select courses available in Spanish. Below is a summary of select new CDRH Learn modules for 2018 to date:

Other News:

• In January 2018, the FDA issued a statement that they would “seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products.” This will be an important area to watch as to how it transpires due to its implications.
• A new Medical Device Development Tool (MDDT) for cardiovascular products was qualified by the FDA; the MDDT Qualification Decision Summary for the “Minnesota Living with Heart Failure Questionnaire” (MLHFQ) tool can be found here. For more information on the FDA’s MDDT program, visit the FDA’s website.
• The FDA has recently started posting online performance metrics for accredited third party reviewers of 510(k)s and plans to publish the reports every quarter; the performance reports for the first two quarters of Fiscal Year 2018 can be found here.
• The FDA has released a summary of the Center for Devices and Radiological Health (CDRH) 2016-2017 Strategic Priorities and results (spoiler alert: FDA states that each of their targets were met or exceeded) as well as a summary of priorities for 2018-2020. A full list of the results for the 2016-2017 CDRH Strategic Priorities can be found here, while full details of the 2018-2020 priorities can be found here.
• For more FDA news, including FDA press releases on new device types or significant medical device clearances or approvals, see FDA’s News & Events page.

Want to Stay Updated on FDA News?
The FDA offers subscriptions to various mailing lists so you may stay updated on changes as they occur; visit their website to subscribe to the CDRH mailing lists.

NAMSA Resources
NAMSA has several resources available related to n various FDA-related topics, including the following:

NAMSA Webinars

• On-Demand Webinar: Strategies for Selecting the Right In Vivo Models for Regulated Preclinical Studies
• On-Demand Webinar: Reimbursement Opportunities and Challenges In 2020: Factors for Success – A Namsa and Kalms Consulting Sponsored Q&A Panel Discussion

NAMSA Blog

• Blog Post: FDA Issues New Draft Guidance Document for Pre-Submissions; Some Feedback Timelines Reduced from 70 Days to 21
• Blog Post: Obtaining Actionable FDA Feedback – How to Develop Targeted Questions for Pre-Submission Meetings
• Blog Post: The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
• Blog Post: Why Regional Reimbursement Strategies Could be Right for MedTech

How can NAMSA Help?
Navigating the international regulatory landscape can be overwhelming for any medical device manufacturer. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements and market success.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (read our most recent case study here).

If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.