The U.S. Federal Emergency Management Agency (FEMA) reported the formation of a voluntary agreement under Section 708 of the Defense Production Act for the manufacture and distribution of critical health care resources necessary to respond to a pandemic. The agreement aims to maximize the effectiveness of the manufacture and distribution of such resources nationwide by establishing a united effort between the participants and the federal government for integrated coordination, planning, information sharing with FEMA, allocation and distribution of critical health care resources. An appointed FEMA senior executive will chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic and be responsible for the overall management and administration of the committee, this agreement and resulting plans of action.
The U.S. FDA has scheduled a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for Oct. 7. Members will discuss the PMA for the Transmedics Organ Care System (OCS) - Heart, from Transmedics Inc., of Andover, Mass.
The FDA also is hosting an Aug. 27 webinar for developers and manufacturers of neurological and physical medicine devices on the de novo pathway. It will explain the agency’s role in facilitating innovation in neurological and physical medicine device technology, as well as give an overview of the de novo classification process.
An inter partes review (IPR) cannot be instituted based solely on statements made by the applicant about prior art in the specification of the challenged patent, the U.S. Patent and Trademark Office (USPTO) said in a memo of binding guidance sent Tuesday to all Patent Trial and Appeal Board (PTAB) judges. The memo reminds the judges that the America Invents Act restricts the basis of IPRs to prior art patents and printed publications. Since a patent cannot be prior art to itself, “the challenged patent itself, or any statements therein, cannot be the ‘basis’ of an IPR,” the agency explained. However, it noted, such statements “may provide evidence of the general knowledge possessed by a person of ordinary skill in the art and may be used to support an obviousness argument in conjunction with one or more prior art patents or printed publications.” In the past, according to the USPTO, some PTAB panels have used an admission in the specification of a challenged patent in instituting IPRs based on their interpretation that the admission was prior art and it was found in a patent. Such interpretations had created confusion among the various PTAB panels, the agency said.
The U.S. Securities Exchange Commission (SEC) will hold an open meeting Sept. 16 to consider amendments to modernize Rule 14a-8, which governs the inclusion of shareholder proposals in a company's proxy statement. If approved, the amendments would mark the first change to the shareholder-proposal process in more than 35 years. The amendments "recognize the significant changes that have taken place in our markets in the decades since these regulatory requirements were last revised, including, in particular, the types and use of communications, the types and frequency of shareholder-company engagement and the substantial shift to investing through mutual funds and ETFs, rather than directly by Main Street investors," SEC Chairman Jay Clayton said last November when the amendments were introduced.
Smiths Medical, of Minneapolis, said it had become aware of an issue where certain Medfusion 3500 and 4000 syringe pumps may not operate as expected. Due to a software error, if a bolus or loading dose is interrupted and a specific sequence of events occurs, over- or underdelivery of a bolus or loading dose may occur. The company listed the affected models as the Medfusion 3500 Syringe Pump – Firmware Version 6.0.0 and the Medfusion 4000 Syringe Pump – Firmware Versions 1.5.0; 1.5.1; 1.6.0; 1.6.1; 1.7.0. The action has been designated as a class I recall by the FDA. The company has received four reports associated with this issue, all involving overdelivery of medication. One of these reports resulted in a serious injury; there were no reports of deaths. Software updates will be provided at no cost to all consignees and are expected to be available in late 2021.