The British Standards Institution has made a series of European Standards for medical devices and personal protective equipment used in the context of COVID-19 available on its website. This is to help support the efforts to fight the pandemic.
The EMA increased its general, nonpharmacovigilance fees by 1.6%, effective April 1, in line with the 2019 inflation rate published by Eurostat. All EMA applications received after March 31 will be charged the adjusted fees. The cutoff point for scientific advice and protocol assistance will be the date the request for advice is validated. For annual fees, the new rate will apply at the time of an anniversary date of the decision granting marketing authorization that falls after March 31. In addition to the increased rate, the EMA has set new fees for consultations on medical devices and for assessments.
U.S. Federal Communications Commission (FCC) Chairman Ajit Pai unveiled his plan for a COVID-19 Telehealth Program to support health care providers responding to the ongoing coronavirus pandemic. As part of the CARES Act, Congress appropriated $200 million to the FCC to support health care providers’ use of telehealth services in combating the COVID-19 pandemic. If adopted by the commission, the program would help eligible health care providers purchase telecommunications, broadband connectivity, and devices necessary for providing telehealth services.
The U.S. FDA has proposed the reclassification of certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV (product code MZO) into class II, subject to premarket notification. The agency also has proposed a new device classification regulation with the name "hepatitis C virus (HCV) antibody tests," along with the special controls that it believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. If finalized, this order would reduce the regulatory burdens associated with these devices, as they would only require the submission of a premarket notification. In addition, the agency is proposing the reclassification of nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA (product codes MZP and OBF) into class II. To that end, the agency is considering a new device classification regulation with the name “nucleic acid-based Hepatitis C virus (HCV) ribonucleic acid tests” along with the special controls.
In addition, the FDA in collaboration with other federal agencies and the Institute for Genome Sciences at the University of Maryland, developed quality-controlled reference sequence data for the SARS-CoV-2 reference strain for the U.S. The availability of traceable and quality-controlled data will help COVID-19 test developers and vaccine developers expedite the development of medical countermeasures, identify new or more stable targets for future tests, enable in silico confirmation of targets, support the development of synthetic reference material and enable viral population/quasi species analysis, the agency said.
Recognizing the hardships COVID-19 has imposed, the U.S. Patent and Trademark Office (USPTO) Tuesday extended the deadlines for filing certain patent documents and paying some required fees. “We are working to provide as much relief as possible to our stakeholders, consistent with our ability to maintain the USPTO’s fee-funded operations,” USPTO Director Andrei Iancu said. “We are especially mindful of the outsized impact on small businesses and independent inventors and have provided additional relief for these groups. Ultimately, our goal is to ensure not only that inventors and entrepreneurs can weather the storm, but that they can hit the ground running once it passes.” Other steps the agency has taken due to the emergency include replacing in-person hearings and examiner interviews with virtual meetings.