Going Solo, and Who Needs Government Anyway?

Some days it seems the idea of interdependence is really gaining ground, but then there are days that seem to trash the idea completely. Below are a couple of stories of the latter variety, stories that might seem more pointed to the diversity ethic that is also very much in vogue in these early years of the 21st Century. First, however, we ask whether the FDA’s device center is losing its appetite for heavy-handed regulation.

FDA Going Soft on Software?

The Center for Devices and Radiological Health at the FDA was pretty quiet for the first half of the year, but is a little more active recently. For instance, CDRH published a digital health action plan in response to pressure from Congress, but the plan is also a tacit admission from the agency that its quality systems regulations (QSRs) don’t always work well where software is concerned.

The reader may remember the FDA’s interest in medical device data systems dating back to 2011. Hospital administrators were wary of the cost and hassle of standing up a QSR-compliant regime in the first place, but four years would pass before the agency renounced the idea, undoubtedly with the help of some arm-twisting from Capitol Hill.

The FDA’s digital health innovation action plan includes a precertification pilot that calls for a review of a publisher’s approach to software quality control rather than a full-blown premarket review of each product. The program is limited to items that qualify as software as a medical device (SaMD), however, and excludes items such as software integrated into devices.

The precertification pilot does include site visits, but the agency is willing to conduct virtual site visits in lieu of the real thing. Ergo, one can argue that this is QSR-lite at worst. Still, one has to wonder how much time will pass before an SaMD will start pushing the FDA’s safety and efficacy buttons despite FDA commissioner Scott Gottlieb’s assertion that the program is strictly for “certain lower-risk devices.” That lower-risk assurance seems odd, given that the sponsor will be on the hook for collecting post-market data for that product.

The day one of these calls for a de novo application might herald a time when the agency will scrutinize these SaMDs individually, but how long after that will a sponsor discover they have tripped the class III/PMA trigger? Only time will tell.

Disharmony from Asia

Some see global regulatory harmonization as a pipe dream, and India’s Central Drug Standards Control Organization has released a draft guidance dealing with standards for safety and performance of medical devices that would seem to support that view. This document, which supplements a novel regulatory framework specific to med tech in India, suggests that CDSCO will handle stand-alone software in the same manner as traditional medical devices despite the FDA’s hands-off approach.

CDSCO gave interested parties only three weeks to comment, hardly sufficient time to absorb the implications of such a document, particularly since the document is undated, other than to note the month of publication (July). The agency said it does not want to dictate how a device maker might demonstrate compliance, but the scope of the 27-page document encompasses a wide range of product categories, including combination products, a breadth of scope which might come across to some as lack of specificity disguised as flexibility.

In any case, the document also takes aim at devices “that incorporate software and stand-alone medical device software,” which is where it rubs up against the new approach at FDA in a disharmonious manner.

As noted above, the American regulator is steering an entirely novel tack for its regulation of SaMD, which had said last year would revolved around a guidance drafted by the International Medical Device Regulators Forum. India is not a participant in the IMDRF effort, although it is a member of the Asian Harmonization Working Party (AHWP), which is an IMDRF affiliate and which has inked its own SaMD proposal, said to be built around the IMDRF effort.

One way of looking at this is that the FDA is the outlier and that the disharmony is coming from Silver Spring, Md., and not from New Delhi, although it may be instructive to note that the latter has a very limited body of experience with med tech-specific regulations. Either way, publishers of SaMD will continue to face very different regulatory regimes if they want to do business in both the world’s richest market and its second most populous market.

No DOJ? No Problem

As is commonly known, the Department of Justice does not dive head first into every qui tam action that pops up, but government attorneys seem to be involved in nearly every whistleblower suit that costs the target company money. Celgene of Summit, N.J. offers the exception, getting stung with a $280 million hit in a False Claims Act case that asked the federal government to do nothing more than accept a nice, fat check from the company.

The company denied any culpability, and Celgene may have a case given that the Centers for Medicare & Medicaid Services is somewhat more lenient about off-label use of oncology drugs. However, court documents indicated that Celgene helped patients financially by contributing money to two patient-directed organizations, which were said to have “acted as conduits for Celgene” and thus had “eliminated any price sensitivity” for both patients and prescribing physicians.

The court also said “the United States did not intervene” without comment, although the court pointed to two other qui tam actions against the company, both of which were dismissed.

The biggest problem for Celgene might have been that the company purportedly persuaded physicians to influence guidelines published by the National Comprehensive Cancer Network, and was alleged to have “caus[ed] doctors to change ICD-9 diagnosis codes.” The lay person sitting in a jury box might find it difficult to hear of manipulation of codes used in Medicare billing without thinking the source of that manipulation was up to no good, particularly given how much very visible emphasis there is these days on Medicare fraud.

Status of Medical Device Reprocessor/Refurbisher Liability

Courtney S. Young, Esq. |Senior Attorney, Medmarc Risk Management

Status of Reprocessor Liability

The recent pressures to drive down the cost of medical care have given way to a practice of using medical devices (even so-called “single-use devices”) a greater number of times, on a greater number of patients, before disposing of them. To accomplish this, hospitals are increasingly using reprocessors to sterilize and re-validate their devices between uses. Although device reprocessing is nothing new, the increase in demand has largely altered the general practice from one in which hospitals sent its devices to a reprocessor and got those exact units back after reprocessing, to one in which the reprocessor provides the hospital with the same model of devices that the hospital submitted but not necessarily the same specific units submitted. This allows for a faster turn-around time.  In this process, the reprocessor may often re-serialize the devices and alter the labels, warnings, or instructions for use, hopefully to account for any additional precautions medical personnel must need to take in light of the manner of reprocessing.

FDA Regulation

Medical device refurbishing is an interesting area right now as it has recently become a focus for FDA and a potential subject of new regulation. Last Spring, the FDA sought industry feedback on proposed definitions including repair, refurbish, remanufacture, recondition, and remarket. At the same time, the Agency also solicited answers to questions about the risks and failure modes introduced as a result of performing these activities on medical devices, and whether the risks were different depending on who performs the activities (hospitals, OEMs, third parties). Thus far, though over 200 comments were submitted in response to these questions, there has not been any further movement from the FDA in this area. Many have speculated that when the Agency does take action, it will likely be to bring refurbishers under the same oversight scheme as reprocessors of single-use devices.

Kapps v. Biosense Webster, Inc.

Although the presence of reprocessors in the chain of distribution presumably has products liability implications for the original-equipment manufacturers (OEMs), few cases have addressed the issue of strict products liability for manufacturers when a device malfunctions after it has been reprocessed or refurbished. The most recent case that really explored this issue was Kapps v. Biosence Webster, 813 F.Supp.2d 1128 (D.Minn. 2011), a case that came out of the Federal District Court of Minnesota in 2011. Though several years old now, the Court’s analysis provides some valuable insights into distinctions that may be important in deciphering products liability apportionment between OEMs and reprocessors. It’s easy to extrapolate that similar reasoning would apply to refurbishers.

In Kapps, the plaintiff was an atrial fibrillation patient that underwent a procedure in which doctors used a “lasso catheter” that had been reprocessed.  During the surgery, the lasso portion of the catheter separated and remained entangled in the plaintiff’s mitral valve. It was eventually able to be removed by the doctors, but the damage that was sustained to the plaintiff’s mitral valve in the process necessitated additional open-heart surgery and replacement of his damaged valve with a prosthesis.

The plaintiff brought the usual products liability claims—manufacturing defect, warning defect, design defect, breach of warranty, and negligence—against both the OEM and the reprocessor.

The Court held:

  1. Plaintiff cannot rely on res ipsa loquitor to establish the OEM’s liability for manufacturing defects.

Res ipsa loquitur is a doctrine used in negligence and products liability actions when the plaintiff has incurred some harm, but obvious difficulties may make too difficult for the plaintiff to prove the exact origin of the cause of harm. In order to utilize res ipsa, plaintiffs (generally) must first establish both that (1) the accident—here, the defect in the product—is the kind that would usually be caused by negligence; and (2) that the defendant had exclusive control over the instrumentality that caused the accident—here, the manufacture and composition of the device.  In disallowing the plaintiff to rely on res ipsa against the OEM, the Court relied on the fact that at the time of injury, the reprocessed device could not be said to have been in the same condition it was when it left the OEM’s control. In effect, the second prong was not satisfied as the OEM did not have exclusive control over the condition of the catheter once the reprocessor was used.

  1. Claims against the reprocessor are viable under theory of res ipsa loquitor.

In contrast, because the reprocessor did have exclusive control over the condition of the catheter as it was at the time of the injury, the Court held that res ipsa loquitur could be applied to the negligence claim against the reprocessor.

  1. An OEM that markets its device as single use will be immunized against the claim that it nonetheless should have foreseen and warned that a reprocessor might ignore the single-use instructions.

In Kapps, the OEM of the catheter has specifically labeled the device, and included in its instructions for use, that it was intended for single use only. Nonetheless, the plaintiff claimed that the OEM should have foreseen that the catheter would likely still be reprocessed despite such instructions, and warned accordingly of the dangers of reprocessing. The Court rejected this claim.

  1. Reprocessor carried a manufacturer’s duties to warn and to provide a defect-free product, because it acted (a) replaced the OEM’s instructions for use and product serial numbers with its own; (b) warranted the functionality of the reprocessed device; and (3) marketed the product as its own equivalent to the OEM’s.

The reprocessor responded to the warning-defect allegations of the plaintiff’s by asserting that the duty to warn should lie only with the OEM. The Court did not find this argument compelling, and instead held that the reprocessor in these circumstances indeed had the same duty to warn as an OEM has.

Kapps can provide helpful guidance for OEMs and reprocessors alike.  For OEMs, it may be reassuring that they may not be strictly liable for manufacturing defects after the their device has been reprocessed, but they must be careful to include warnings and instructions for reprocessing and its dangers if in fact their device is not designated for single use only. Reprocessors should be mindful of enlarging their own products liability when they mix, re-serialize, and alter the warnings and labels of an OEM’s devices.

State Statutes

In the years since Kapps, courts haven’t been asked to reconsider the issue of reprocessor/refurbishers liability hasn’t come before the courts again, so it’s the best indication we’ve got as to how courts are likely to treat reprocessor liability going forward. That said, several states aren’t waiting for the courts to decide, and some have enacted statutes specifically deeming reprocessors and refurbishers to have the same liability with respect to a defective device as original manufacturers. See, e.g., Utah’s statute, U.C.A. 1953 § 78B-4-505. Liability of reprocessor of single-use medical devices.

Conclusion

The safest course for reprocessors and refurbishers of medical devices is probably to assume that they may stand in the shoes of the OEM if something goes wrong with the device they process. In doing so, they should implement a quality management system and undertake the same robust risk management practices of which successful OEMs make use.

Boomerang: EMA Goes from Hunter to Hunted

Boomerang: EMA Goes from Hunter to Hunted

Regulatory agencies spend more time investigating others than being investigated by others, but the European Medicines Agency is now on the hot seat over what is purported to be a lack of transparency regarding premarket interactions between it and drug makers. This is quite a reversal of the typical dynamic, such as when the EMA orders drug makers to withdraw their products from the EU market, but companies in the life sciences might not think the agency’s new transparency problem is a good problem for industry.

EU Ombudsman Investigating Presubmission Meetings

Allegations that regulators are all to cozy with industry are typically leveled at the American FDA, but that problem seems to have migrated to the other side of the Atlantic Ocean. Former journalist Emily O’Reilly, who took the job of European Ombudsman in 2013, has advised the European Medicines Agency she intends to open a “strategic inquiry” into pre-submission activities between the European Medicines Agency and regulated entities.

O’Reilly is no stranger to controversy, having penned three books that struck a number of nerves, but she also took the government of Ireland to task for what she saw as a problem with transparency. The theme of transparency appears in her July 17 letter to EMA executive director Guido Rasi, which states that pre-submission interactions with EMA staff and industry “may pose some risks,” such as that reviewers at EMA may be influenced by applicants in these interactions. O’Reilly acknowledges that these pre-submission meetings are not necessarily problematic, but said there is risk that these meetings create “in the eyes of the public, at least some perception of bias,” a hazard she asserts “must be managed.”

This risk could be managed by more transparency, O’Reilly continues, stating also that “a preliminary assessment suggests that more could be done in this area” without offering any details related to that preliminary assessment.

O’Reilly inquired as to whether EMA publishes “detailed minutes of pre-submission meetings,” which may strike some in industry as incurring the hazard of loosing the lid on proprietary information. She asked EMA to provide details of such meetings dating back to 2012, and asked for a list of the 10 companies that “met most frequently” with EMA staff in pre-submission meetings.

The inquiry is certain to raise a few hackles, but it’s anyone’s guess as to how far this will go and whether EMA will find this sufficiently distractive to impede the agency’s handling of priority review applications, which are also referenced in O’Reilly’s letter. At the very least, this is a matter that bears watching.

EMA Hits Gadoliniums After FDA Stands Pat

The EMA is no stranger to imposing its will on others, as demonstrated by the fact that it has followed through on a threat to suspend the marketing authorization for three gadolinium-based MRI imaging agents, a move that was not paralleled in a similar FDA review. Among the products up for suspension is one route of administration for Magnevist, a linear gabapentin-based contrast agent (GBCA) manufactured by Bayer Schering Pharma, but the macrocyclic GBCAs escaped relatively unscathed in this review.

The FDA began its investigation into the effects of deposits of GBCAs in human tissues in 2015, but announced in May that it had no data on hand to suggest that retention of these agents in the brain is harmful for most patients. The agency affirmed the notion that linear GBCAs are more the more likely of the two types to be retained in the human body, and said the only known problem is nephrogenic systemic fibrosis, said to occur only in “a small subgroup of patients” who had been diagnosed with kidney failure. The FDA said it would continue to track these patients.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said earlier in July that it had confirmed “that there is convincing evidence of gadolinium deposition in brain tissues” with the use of gadolinium contrast agents, but while PRAC did not identify specific conditions in connection with deposits in the brain, the committee recommended that EMA suspend the use of Magnevist (gadopentic acid) and two other linear GBCAs, Omniscan (gadodiamide) and Optimark (gadoversetamide).

EMA’s July 21 announcement confirmed the suspension of marketing authorizations for the three linear agents cited by the PRAC, while stating that another linear GBCA, Multihance (gadobenic acid) should be restricted to use in scans of the liver. Another linear GBCA, Primovist (gadoxeticacid), was untouched by the EMA action, although it should be noted that the agency will allow Magnevist to stay on the market for intra-articular use despite the suspension of its use via intravenous administration.

Venue, Preemption Issues Dot Legal Landscape

The Supreme Court has been busy of late on several fronts of interest to those in the life sciences, and may be busier yet if it accepts a case dealing with preemption. The Court decided a case recently dealing with venue, but there is some disagreement as to how much that decision clarified the questions at hand.

Is Lohr back in play?

Those who find the PMA preemption discussion fascinating will enjoy the potential for a reexamination of preemption for class II devices if the U.S. Supreme Court grants cert for a case addressing surgical meshes. One of the more interesting aspects of this case is that any push for 510(k) preemption might be due to more stringent requirements for these applications imposed by the FDA over the past few years.

J&J subsidiary Ethicon requested cert for Ethicon v. Huskey, which takes up a synthetic surgical mesh applied for stress urinary incontinence. The jury trial returned an award of more than $3 million for the plaintiff, and Ethicon appealed the case on the grounds that the judge in the first trial disallowed evidence as to the company’s adherence to FDA premarket requirements, along with several other bits of regulatory information related to the device.

The appeals court sided with the district court, citing with the Federal Rule of Evidence 403 as justification for omitting the evidence in question, but the appeals court decision also argued that 510(k) filings only “tangentially” deal with safety and efficacy. The court cited Medtronic v. Lohr without comment in this section, which seems likely to provoke a discussion as to whether the FDA’s increasing demands from FDA for 510(k) filings begins to approach the threshold for specificity that is the foundation for PMA preemption. Or at least that’s the argument device makers are inclined to make.

Either way, Lohr dealt with the statute as it existed in 1982, when the FDA cleared the Model 4011 pacemaker, and thus changes imposed by Congress since then, including the Safe Medical Devices Act of 1990, were not considered. This legislation was driven almost entirely by concerns about the tracking of adverse events for class II devices, but the Supreme Court decision in Lohr claimed that a typical 510(k) review takes only 20 hours as opposed to the average of 1,200 hours needed to review a PMA filing.

Whether those times still hold is difficult to know, but the most recent FDA performance report for the soon-to-expire device user fee agreement suggests that overall PMA review times are down to 163 FDA days while the target for 510(k) review times is still 90 FDA days. The question one might ask oneself is: If it takes the FDA 90 days to get through 20 hours of review time for a 510(k), how can it take only 163 days to put 1,200 hours into a PMA?

Venue, vidi, vici

Those who see the question of forum shopping in a negative light might be encouraged by a recent decision in the Supreme Court that seems to put the clamps on this practice. The fact that the decision in Heartland v. Kraft was unanimous would seem to bring the venue question to a thunderous close, but there is some skepticism as to whether the question is fully answered.

Justice Clarence Thomas wrote the 8-0 decision in Heartland  – Justice Neil Gorsuch did not take part – and said that §1400 of Title 21 of the U.S. Code was unaffected by congressional modification of Title 21’s §1391. Thomas also pointed to Fourco Glass v. Transmirra Products, the 1957 case in which the Supreme Court declared that the word “resides” means the location of incorporation for a U.S. domestic company.

Former PTO director Todd Dickinson noted that the outcome leaves a few questions unanswered about cases that are already in process, but he also said that stand-alone legislation by Sen. Jeff Flake (R-Ariz.) directed toward venue might be futile. On the other hand, former Senate Judiciary Committee chairman Orrin Hatch said he will draft a bill to take up the vexatious venue problem, so there is clearly some interest on Capitol Hill.

There are those who believe that Heartland might influence whether patent litigants will resort to multidistrict litigation to go after infringers. The America Invents Act disallowed the use of joinder based merely on the charge that each of the named defendants infringed the same patent, and Heartland would seem to suggest that a patent holder will spend a lot more time on the road in pursuit of damages, although a lot of potential targets are located in Delaware thanks to that state’s status as the home of the limited liability corporation.

Multidistrict litigation might seem a handy way to pursue infringers in numerous jurisdictions, but MDLs are infrequently used for patent cases. Would the U.S. Judicial Panel on Multidistrict Litigation (JPML) be persuaded by an application to consolidate patent lawsuits when only half a dozen or so defendants are named? By some accounts, patent MDLs currently account for less than 5 percent of all MDLs, although this might reflect nothing more than underutilization.

Still, it seems plausible that a plaintiff will have to identify a very similar set of allegations for a given number of defendants in order to prod the JPML into action. A lack of sheer numbers presents one problem, but the combination of small numbers and dissimilar allegations could prove fatal to an effort to consolidate patent lawsuits via the JPML.

Life Sciences News Roundup, 6/22

Courtney S. Young, Esq. | Senior Attorney, Medmarc Risk Management

MedPAC Calls for Action to Reduce Number of PODs 

On June 15, the Medicare Payment Advisory Commission (MedPAC) issued its annual report, which enumerated problems with PODs and outlined actions that could be taken to reduce their prevalence. You can read more here.

FDA Seeks Comment on Two New Drug Promotion Studies

The FDA published two notices in the Federal Register on Monday articulating its plans to undertake new studies on drug promotion: (1) Experimental Study on Risk Information Amount and Location in Direct-to-Consumer Print Ads; and (2) Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion.

 

U.S. Supreme Court Clamps Down on Mass Tort State Court Lawsuits

Jordan Lipp | Partner, Davis Graham & Stubbs LLP

Yesterday morning, in an 8-1 decision, the United States Supreme Court determined that plaintiffs who did not reside in California could not sue Bristol-Myers Squibb in California.  The decision is the latest one in a string of decisions from the United States Supreme Court, which are limiting the scope of personal jurisdiction – i.e., where a company can get sued.  The question of where a company can or cannot get sued is one of the most important issues in defending lawsuits against life science companies.  And this lawsuit is a classic example of these issues.

As discussed more in earlier blog posts as we’ve followed this litigation, this appeal involved personal jurisdiction issues in a case where 678 individuals, consisting of 86 California residents and 592 nonresidents, all alleged adverse consequences from the use of Bristol-Myers Squibb’s drug Plavix.  Bristol-Myers Squibb is incorporated in Delaware, headquartered in New York City, with substantial operations in New Jersey.  The lawsuits were filed in San Francisco Superior Court.  Bristol-Myers Squibb challenged the jurisdiction of California courts to hear the claims of plaintiffs who did not reside in California.  While the California Supreme Court found there was no general jurisdiction (i.e., whether a defendant can be sued in the forum regardless of whether the case is related to the forum), the California Supreme Court found that there was specific jurisdiction (i.e., case-linked jurisdiction) due to Bristol-Myers Squibb’s “wide ranging” contacts with California.

Yesterday, the United States Supreme Court reversed the California Supreme Court.  As “the nonresidents were not prescribed Plavix in California, did not purchase Plavix in California, did not ingest Plavix in California, and were not injured by Plavix in California,” the United States Supreme Court Court found specific jurisdiction lacking.  Specific jurisdiction in these circumstances is absent no matter how many other connections Bristol-Myers Squibb had to California, no matter how many California residents had sued Bristol-Myers Squibb for the same conduct in California, and no matter how efficient having combined litigation  in California might be.  While hardly a surprising ruling, this decision could have far reaching consequences in large-scale drug and device litigation.  While a drug or device company can be sued in the state in which it is headquartered or incorporated (i.e., the concept of general jurisdiction), it will be much harder for plaintiffs to sue drug and device companies in any other plaintiff-friendly jurisdictions.  Rather, this Bristol-Myers Squibb decision will continue the trend in confining plaintiffs to suing drug and device company only in their own home-state, or where the drug or device company is headquartered / incorporated.

Biosimilars, Biostatisticians, and the New EEU

There are very few days during which the worlds of drugs and medical devices are entirely quiescent, thanks to very active American courts and international regulatory churn. There is some good news in all this, but how good is it?

If you’re in the biosimilars business, the latest news is quite good, indeed.

SCOTUS rules for Sandoz

The U.S. Supreme Court ruled on June 12 that makers of biosimilars do not have to wait six months after the issuance of a biologics license application to begin marketing that product, a development that could bring some less costly biotech drugs to market more quickly and possibly take a bite out of spending on these agents.

In a 9-0 vote, the Court ruled in favor of Sandoz in Sandoz v. Amgen, a case that made a stop at the Court of Appeals for the Federal Circuit, where the outcome was quite different. Sandoz had argued that the terms of the Biologics Price Competition and Innovation Act of 2009 had essentially worked to add half a year of exclusivity to the 12 years already granted by the statute, and by some accounts, Sandoz’s Zarxio is about 15 percent less expensive than Amgen’s Neupogen, a drug for chemotherapy-induced neutropenia.

The news might not change the field dramatically in the near term, given that the FDA has approved only about half a dozen biosimilars to date, but one possible candidate for a quick entry to market is an oncology biosimilar for Avastin, which will undergo an FDA advisory committee review in mid-July. In an ironic twist, Amgen teamed up with Allergan to produce this biosimilar.

Expert witness refuted in Zoloft lawsuit

Pfizer scored a victory in the running lawsuit pertaining to the company’s flagship antidepressant Zoloft, but what may have been the most interesting part of this story is that a court rejected expert testimony relating to allegations that the selective serotonin reuptake inhibitor (SSRI) causes congenital heart defects.

The decision may have brought to a close an effort by more than 300 litigants, which absorbed a second consecutive negative outcome in the U.S. Court of Appeals for the Third Circuit. Both the appeals court and a district court decreed that the expert witness, Nicholas Jewell, a biostatistician at the University of California at Berkeley, had failed to plausibly link the drug to the birth defects. Among the problems with Jewell’s presentation is that he had rejected meta-analyses he had previously cited in a separate lawsuit pertaining to another SSRI.

Whether the plaintiffs will take this lawsuit any further is difficult to forecast, but a footnote on page 10 of the Appeals Court decision remarked that the plaintiffs’ attorneys had conceded that they are “unable to establish general causation” if the courts jettisoned Jewell’s testimony. Summary judgment was granted in favor of Pfizer.

This is not the only multi-district litigation keeping attorneys at Pfizer busy, however. A very active set of lawsuits dealing with proton pump inhibitors and purportedly associated kidney damage would seem to implicate the OTC version of Nexium, marketing rights for which Pfizer picked up five years ago in a deal with AstraZeneca. The U.S. Judicial Panel on Multidistrict Litigation (JPML) declined in January to consolidate these lawsuits, but another motion for consolidation has been filed by attorneys with Seeger Weiss of New York.

Regulations, regulatory agreements on the move

Efforts to ramp up medical device regulatory schemes in outside-U.S. jurisdictions are nothing new, but device makers can add Malaysia and the Eurasian Economic Union (EEU) to the list of national and international entities diving into deeper regulatory waters. The news for device makers is somewhat mixed, but greater clarity alone is sometimes enough to overcome other considerations.

First, Malaysia’s Medical Device Authority has declared that adverse events associated with medical devices will have to be reported to the agency within 30 days. This apparently applies to all devices that are on the Malaysian market, regardless of where the adverse event took place. Any fatalities have to be reported within 10 days, and device makers have a mere 48 hours to advise the agency of any problems that might carry a public health consideration.

The EEU continues to work toward a single market for drugs and devices, a move which if successful would capture the markets of Russia and four other nations for a total 2015 population of nearly 184 million. There are reports that Tehran is interested in a free trade agreement with the EEU, although there is no indication that Iran would take part this new med tech regulatory bloc despite the deepening geopolitical ties with Moscow. Serbia is likewise said to be interested in doing business with the EEU, but it’s not clear whether Belgrade has full-blown membership in mind, either, although the protracted and difficult negotiations for entry into the European Union might strike some as suggestive.

To date, the EEU regulatory regime lacks several critical documents, such as a framework for quality management systems. Registration requirements for this international regulatory system would be phased in over the next four years, however, giving industry a little breathing room for offerings already available in this market.