The opening days of a new year are, to some, an apropos time to look back and reflect on the year that is now “one for the books.” Unable to resist the urge to do so ourselves, we have compiled our “Top-5” list for medical device regulation in 2016.
Device Modification Guidance
It has been said that the one constant in life is change and some could easily argue that this maxim applies to medical device technologies which appear to be evolving at an ever increasing rate. As manufacturers seek to keep pace with technology, they are often faced with the need to apply recent innovations and “lessons learned” to their existing 510(k)-able devices. As one can never be completely certain that FDA would not view such changes as “significant” and triggering the requirement for a new 510(k) submission, prudent manufacturers have analyzed such changes pursuant to the 1997 guidance, Deciding When to submit a 510(k) for Changes to an Existing Device, and documented their analyses in a regulatory “Letter to File” should FDA come ‘a knocking.
In August, FDA finally issued a draft update to this guidance almost 19 years after the original was finalized. (Apparently, some things evolve more slowly than others.) When finalized, this guidance will affect how manufacturers analyze and document these changes as it incorporates some concepts not well developed in its predecessor. For example, the draft highlights the fact that changes to improve safety or efficacy are amongst those changes that are more likely to require a new 510(k) submission. Whether or not such emphasis will deter conscientious manufacturers from implementing safety enhancing modifications will be something to watch in 2017 and the years that follow.
Likewise, the draft guidance appears to take aim at those manufacturers who have previously evaluated changes using a “yes/no flowchart” analysis and, instead, places emphasis on the need to conduct risk analyses in evaluating such changes. The draft also includes a sample “Regulatory Change Assessment” document that appears to strongly reinforce the notion that the former “yes/no flowchart” practice is no longer acceptable.
We anticipate that many RA/QA personnel will be facing new challenges in 2017 as a result of this new draft guidance.
Laboratory Developed Tests
November of 2016 brought a sudden reversal of direction for the agency when it announced that it would not seek to finalize its draft guidance for Laboratory Developed Tests (LDTs). As the some of the agency’s efforts to regulate LDTs arguably pushed the limits of the agency’s lawful authority which would require support from the administration, it appears to have been a reasonable decision for FDA to back away from these efforts following last November’s election results and the prospect of a deregulation-minded new administration. Given the agency’s emphasis on safety during their prior efforts to regulate LTDs, we find it unlikely that the agency will abandon the field. Rather, we would expect the agency to continue the fight in a more subdued manner in 2017 while capitalizing on its prior successes to the extent possible, e.g., enforcement of the established 2013 RUO/IUO guidance.
Medical Device Reporting
In November, FDA published its revised final guidance on “Medical Device Reporting for Manufacturers.” In the main, there are few significant surprises when compared to its progenitor that was published in 1997. Rather, and by way of improvement, the new guidance provides some much needed clarification on critical MDR topics contained in the prior version. To do so, the agency capitalized on its prior use of the “question and answer” format supplemented by illustrative examples. Some of the more notable of these included:
- Emphasis on the obligation to report instances of “user error” as an MDR reportable event;
- Required MDR reporting of adverse events that occur outside the United States; and
- MDR reporting requirements when a marketed device is also the subject of an investigational device exemption (IDE).
The final guidance, however, did not include all of the concepts that were contained when it was first released in draft form. The draft included language that would have required contract manufacturers and specification developers to both file MDR reports for identical events.
Likewise, the final guidance dropped language that would have served to make a device alarming prior to a malfunction, to allow a clinician to intervene to avert an adverse event, an MDR reportable event. Also deleted was language that would have required manufacturers to submit data and justifications for ceasing the reporting of events falling under the two-year presumption that a reportable malfunction would be ‘likely” to contribute to a death or serious injury if it were to recur in the future.
Another interesting development in 2016 was FDA’s establishment of its online reporting program. In a way that is somewhat reminiscent of the anonymous tip portal used in the mid-1990’s against the much scrutinized dietary supplement industry, this more recent iteration uses a web-based form to encourage the submission of “tips” and other information regarding medical devices. According to the agency’s website, the information submitted by members of the general public will be used to help FDA identify risks to health, set investigational priorities, and assess the potential need for enforcement actions.
While the effort appears to be born of a laudable intent to protect the public health, the more cynical amongst us may describe the program as a governmental “snitch line.” Without regard to the intent behind the program, there is no evidence of what kind of action, if any, FDA has taken to ensure that the program does not encourage frivolous misuse or to facilitate malicious abuse.
(No politics!)In 2017, we will keep an eye on this program and the uses to which the agency puts it.
FDA’s Prohibition Against Off-Label Promotion
For years, the agency has taken a well-documented and, some would say, draconian view of off-label promotional activities. However, as time marched on, the agency’s position that such activities are a per se violation of the law is getting less deference by the courts when FDA and DOJ continue to initiate prosecutions based on the dissemination of truthful and non-misleading information by FDA-regulated firms. This trend continued in 2016 in the United States District Court for the Western District of Texas. The jury in United States v. Vascular Solutions, Inc. found Vascular Solutions, Inc. (VSI), and its Chief Executive Officer to be not guilty of, among other things, conspiracy to distribute, and the distribution of, misbranded and adulterated medical devices, in violation of the Food, Drug, and Cosmetic Act (FDCA) based on the allegation that the company’s Vari-Lase device was being distributed for a new and off-label intended use.
Given the right set of circumstances and FDA’s view of off-label promotional activities, we would expect 2017 to provide additional opportunities for the courts to continue their support for First Amendment rights (at least in criminal cases) regarding the dissemination of truthful and non-misleading information over FDA’s somewhat more narrow interpretation of such rights.