Most of the decisions arising from the inter partes review (IPR) process used in the U.S. patent system are the final word on the related patent dispute, but Guardant Health Inc., managed to at least temporarily reverse such an outcome recently. The Court of Appeals for the Federal Circuit reversed an IPR determination that 16 claims found in a patent held by Guardant were obvious and kicked the case back to the Patent Trial and Appeal Board (PTAB) for further consideration, but the affected patent is not clear of an adverse determination just yet.
A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress.
The U.S. Preventive Services Task Force (USPSTF) is proposing to lower the age of onset of regular breast cancer screening to 40 years, a massive jump of 10 years over the current recommended age of 50 years. While this is just a draft proposal, analysts who track the medical device industry say that medical imaging manufacturers, such as Marlborough, Mass.-based Hologic Inc., could see a significant uptick in demand for their systems, a much-needed boost as the drop in demand incurred by the COVID-19 pandemic comes to an end.
The recent decision by the EU to delay the implementation dates for the Medical Device Regulation (MDR) initiative is having ripple effects across the globe as other regulatory jurisdictions amend their policies to keep pace. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia’s Therapeutic Goods Administration (TGA) have both revised their strategies to align with the latest MDR delay, giving devices that will remain available in the EU a similar extension in the U.K. and Australia.
The regulatory record for successful replacements of the human meniscus is thin, but the latest attempt came up short as a U.S. FDA advisory committee voted 6-2 that the benefits of the Nusurface device by Active Implants LLC did not present an acceptable benefit-risk ratio. The device is commercially available in both the European Union and in Israel, however, suggesting that Memphis, Tenn.-based Active will not give up on the massive U.S. market, which offers a patient population that will undergo a tsunami of total knee replacements in the decades ahead unless a solution for the epidemic of cartilage degeneration can be found.
The U.S. Centers for Medicare and Medicaid Services’ years-long musing over a streamlined coverage policy specifically for breakthrough medical devices is now taking a toll on breakthrough medications that could provide a cure or arrest the progression of debilitating diseases.
For several years, the U.S. CMS has been musing a coverage policy specifically for breakthrough medical devices, and the absence of activity on this front has once again drawn the attention of Congress. Rep. Cathy McMorris Rodgers (R-Wash.), said a representative of CMS had recently appeared before a House subcommittee for the first time in four years, and that the subcommittee is prepared to act on breakthrough devices coverage if CMS doesn’t produce a final rule this year.
Regulatory harmonization is perhaps highest on the regulatory wish list of medical device manufacturers, but the FDA’s device center has tamped down expectations of a medical device single review program. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) said the agency will release a strategic plan later this year for regulatory harmonization, but declined to offer any details other than to state that differences in risk classification schema are not as significant a source of drag on harmonization as may commonly be believed.
Four U.S. government agencies have issued an advisory regarding bias in the use of artificial intelligence (AI) and other automated systems, the scope of which includes software products that “make decisions.” The four agencies have pledged to use their enforcement powers to “protect individuals’ rights regardless of whether legal violations occur through traditional means or advanced technologies,” all of which sends a signal to developers of medical software that the FDA is not the only federal government agency that will be looking over their shoulder to evaluate the risk of bias in those algorithms.
Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
