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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.

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 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January 17, 2018 Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Draft Guidance for Industry and FDA Staff Draft Related reading: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
FDA Blog


June 13, 2018 Humanitarian Device Exemption (HDE) Program – Draft Guidance for Industry and Food and Drug Administration Staff Draft Open for public comment until August 13, 2018 under Docket No. FDA-2014-D-0223.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.
Additional questions related to combination products that contain an approved drug have been added as well as additional clarifying language related to ClinicalTrials.gov certification, Pediatric use, etc.

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


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:

FDA Press Release

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


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.

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.

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
Radiation-Emitting Products
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

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


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.

Kristy Katzenmeyer-Pleuss

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).