Mid-Year FDA Regulation & Guidance Review
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.
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 21st 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.
|Date Issued||Guidance Title||Draft or Final||Notes|
|May 2018||Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs||Final||Harmonizes differences in human subject regulations under HHS and FDA. Guidance includes a Written Procedures Checklist to assist in preparation and maintenance of written procedures.|
|January 25, 2018||Payment and Reimbursement to Research Subjects – Information Sheet||Final||Brief guidance for IRBs and clinical investigators|
|January 17, 2018||Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Draft Guidance for Industry and FDA Staff||Draft||Related reading:
FDA Press Statement
|June 13, 2018||Humanitarian Device Exemption (HDE) Program – Draft Guidance for Industry and Food and Drug Administration Staff||Draft||Open for public comment until August 13, 2018 under Docket No. FDA-2014-D-0223. Guidance was issued to explain the criteria the FDA uses to assess probably benefit and risk for an HDE application, provides interpretation of the term “appropriate local committee” to approve the use of a Humanitarian Use Device (HUD) at a healthcare facility and to “answer common questions about the HDE program, including FDA actions on HDE applications, post-approval requirements and special considerations for devices marketed under the HDE program.”|
|June 7, 2018||Feedback and Meetings for Medical Device Submissions: The Q-Submission Program||Draft||Open for public comment until August 6, 2018 under Docket No. FDA-2018-D-1774. Draft released in response to the goals within the 2017 Medical Device User Fee Amendment (MDUFA IV) and intended to replace the September 29, 2017 Final Guidance.|
|May 31, 2018||Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions||Draft||Open for public comment until July 30, 2018 under Docket No. FDA-2018-D-1329. Explains the FDA’s current expectations regarding the content and format of test reports for bench performance testing into a formal guidance (no new changes).|
|April 27, 2018||Multiple Function Device Products: Policy and Considerations – Draft Guidance for Industry and Food and Drug Administration||Draft||Open for public comment until June 26, 2018 under Docket Number FDA-2018-D-1339.
Clarifies that FDA will not regulate the functions of multi-function devices that do not meet the definition of a medical device or that are currently subject to enforcement discretion.
|April 12, 2018||Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria – Draft Guidance for Industry and Food and Drug Administration||Draft||Describes an additional optional pathway for specific well-defined device types in which the new device can be demonstrated to meet FDA-identified performance criteria.
FDA intends to publish a list of applicable device types on their website along with the applicable performance criteria, which will be identified in an accompanying guidance document.
Substantial equivalence to a predicate device must still be demonstrated as well.
|February 21, 2018||Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions – Guidance for Industry and Food and Drug Administration Staff||Final||Communicates FDA’s policy requiring that clinical studies conducted outside of the United States (OUS) must be conducted in accordance with Good Clinical Practice (GCP)|
|January 30, 2018||Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff||Final||Replaces previous “Refuse to Accept Policy for 510(k)s” guidance issued August 2015 and now included questions on whether the product is a combination product containing an approved drug under exclusive marketing rights.|
|January 30, 2018||Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) – Guidance for Industry and Food and Drug Administration Staff||Final||Replaces previous “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)” guidance issued December 2012.
Previous Filing review requirements are now split into a new Acceptance Review (completed by FDA within 15 days of PMA receipt) and the Filing Review (timeline unchanged; completed by FDA within 45 days of PMA receipt).
Manufacturing section now to be included with the PMA; FDA will no longer allow for a 90-day delay in submission of the manufacturing section.
|January 19, 2018||Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) – Draft Guidance for Industry and Food and Drug Administration Staff||Draft||Summarizes FDA’s expectations for using conformance to specified IEC standards to meet FDA’s performance standards for laser products found in regulations under 21 CFR 1040.|
|January 16, 2018||Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff||Final||Establishes dates of enforcement for UDI labeling, GUDID data submission, standard date format, and direct marking requirements for Class I and unclassified devices between September 24, 2020 up to September 24, 2022|
|March 21, 2018||Compliance Policy for Combination Product Postmarketing Safety Reporting||Final||Guidances issued to discuss FDA’s compliance policy for and how to comply with the final rule on postmarketing safety reporting requirements for combination products issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4, Subpart B.
|March 21, 2018||Postmarketing Safety Reporting for Combination Products||Draft|
|February 14, 2018||How to Prepare a Pre-Request for Designation (Pre-RFD) – Guidance for Industry||Final||Clarifies FDA’s existing policies for informal inquiries to the Office of Combination Products (OCP) regarding preliminary jurisdictional assessment and establishes the process under what will now be called the pre-RFD program|
IN VITRO DIAGNOSTICS (IVD)
|April 13, 2018||Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics – Guidance for Stakeholders and Food and Drug Administration Staff||Final||Related reading:|
|April 13, 2018||Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases Guidance for Stakeholders and Food and Drug Administration Staff||Final|
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:
|General Topic||Course/Module Title||Course Materials|
How to Study and Market Your Device
|Clinical Studies/Investigational Device Exemption (IDE)||FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions|
|Cross-Cutting Premarket Policy||Combination Product Updates for “Acceptance and Filing Reviews for Premarket Approval Applications” and “Refuse to Accept Policy for 510(k)s”|
Specialty Technical Topics
|Custom Devices||Custom Device Annual Reporting|
|Technical Considerations for Additive Manufactured Medical Devices|
|IT and Software||Digital Health Software Precertification (Pre-Cert) Pilot Program|
|PreCertification (Pre-Cert) Pilot Update|
|Reprocessing||Webinar – Duodenoscope Sampling and Culturing|
|Pediatric Information for X-ray Imaging Device Premarket Notifications|
In Vitro Diagnostics (IVD) Devices
|Final Guidances on Next Generation Sequencing-based Tests|
|CLIA Waiver Applications Draft Guidance Documents|
- 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 has several resources available related to n various FDA-related topics, including the following:
- 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
- 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: email@example.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.
Kristy Katzenmeyer-Pleuss, Ph.D, is a former FDA medical device reviewer and currently a Senior Medical Research Manager, Regulatory at NAMSA. She holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison. Her experience includes developing high-level regulatory strategy and policy, facilitating communications and meetings with regulatory agencies, and drafting premarket submissions and deficiency responses. Kristy has experience with a variety of medical device types and combination products, including general and plastic surgery, wound care, dermatologic, cardiovascular, orthopedic, neural, ophthalmic, ENT, dental, respiratory, infection control, general hospital, digital health, etc. She is also a subject matter expert in biocompatibility and reprocessing (reusable and reprocessed single-use devices).