The recent government shutdown gave us some time to reflect on 2018, a year that was full of device-related posts. Inspired by the recent Academy Awards nominations, we are now listing our Top Ten Device Posts of 2018. Some are blockbusters, and others indie stories, but they all earned a coveted place in the HPM Top Ten. Accompanied by a brief explanation for why they made the list, they are:
The draft guidance indicates that FDA will not regulate functions of a multi-function product that do not meet the statutory device definition or are devices that are subject to an existing enforcement discretion policy. Although issued in the context of medical device software, FDA states that it will apply the same principles to traditional devices as well.
- A Future Regulatory Paradigm with Potential Broader Implications (May 29, 2018) (FDA’s Pre-Cert Program)
FDA’s request for feedback on the Software Precertification Program, in which data is leveraged so that FDA can adopt a risk-based, streamlined approach to Software as a Medical Device review. This could – someday – replace the need for a premarket submission or allow for a streamlined premarket review for higher risk products.
IVD Technical Assistance—2 posts
- FDA’s IVD TA: It’s Not Just Technical Assistance (Aug. 14, 2018)
- HP&M Weighs in on FDA’s “Technical Assistance” to Proposed IVD Legislation (Nov. 2, 2018)
FDA was asked to provide Technical Assistance regarding the Diagnostic Accuracy and Innovation Act (DAIA), intended to provide a regulatory framework for Laboratory Developed Tests. FDA advanced a different framework than that set forth in DAIA, one which essentially revamps the regulation of all In Vitro Diagnostics. These blog posts consider the implications of the proposed changes for industry. Many of these suggestions were incorporated in revised draft legislation. (See our recent post on draft IVD legislation here).
- FDA Issues Final Rule on Voluntary Malfunction Summary Reporting Program for Device Manufacturers (Sep. 25, 2018)
The Voluntary Malfunction Summary Reporting Program permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements. This program has several significant limitations, described in detail in the blog post.
- Final Guidance Issued for Considering Benefit-Risk Factors in 510(k)s with Different Technological Characteristics (Oct. 5, 2018)
FDA sets forth a framework for analyzing the benefit-risk profile of a new device when determining whether it is as safe and effective as the predicate device in the review of substantial equivalence. This guidance is intended to improve predictability, consistency and transparency in the 510(k)-review process.
- If at First You Don’t Succeed, Try, Try, Try Again: FDA Issues Plan to Increase Efficiency of 510(k) Third Party Review Program (Oct. 12, 2018)
FDA announced a plan for revamping the 510(k) Third Party Review Program, including the issuance of a draft guidance that says it all: “510(k) Third Party Review Program.” This blog post reviews the current Third Party Review Program, how this new guidance purports to change it, and our assessment of its likelihood of making a difference.
- FDA Issues Two New Guidance Documents on Voluntary Consensus Standards, Consolidating and Replacing Earlier Guidance (Oct. 30, 2018)
This post reviews two new guidance documents that consolidate information on voluntary consensus standards used in medical device premarket submissions: (1) a draft guidance titled “Recognition and Withdrawal of Voluntary Consensus Standards”; and (2) a final guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
- Possible Major Changes to 510(k) Program Ahead (Nov. 26, 2018)
This post reviews the implications of an announcement by FDA Commissioner Dr. Scott Gottlieb and Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, that FDA is planning to “modernize” the 510(k) process through the elimination of old predicates and the creation of an alternative “Safety and Performance Based” 510(k) Pathway. This new story got a lot of buzz in the broader media.
- Failure to File Adverse Event Reports Results in Criminal Pleas for Medical Device Company and Quality Manager (Dec. 12, 2018)
This post outlines a recent example where the government targeted a manufacturer for failure to file adverse event reports associated with its duodenoscope product, rendering the product misbranded. The plea agreement requires the company to distribute to its U.S. customers a notice about the plea agreement, undertake certain compliance measures specific to MDR processes, and pay a fine of $80 million as well as a $5 million forfeiture.
On December 4, 2018, FDA issued a proposed rule that would govern the de novo classification process. This post analyzes the implications of the proposed rule, including an assessment of whether it unduly increases the burden on applicants. Spoiler alert. We think it does.
Honorable Mention: Draft Guidance Explains how Uncertainty should be Handled in Device Premarket Submissions (Oct. 2, 2018)
This post analyzes FDA’s draft guidance, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions,” which is intended to describe factors that FDA will consider when assessing uncertainty as part of a benefit-risk assessment in PMA, De Novo, and HDE submissions.
In all, 2018 was a year filled with worthy contenders for a Top Ten ranking. With the shutdown, 2019 is off to a slow start, but there’s plenty of time to catch up.