The ASCA pilot accreditation program will allow accredited independent testing laboratories to assess medical devices for compliance with certain FDA-recognized standards. The establishment of the ASCA was mandated under the 2017 FDA Reauthorization Act and is expected to help facilitate a more efficient review process for certain types of medical devices.
According to an announcement posted on the FDA website, the list of accredited laboratories for the ASCA pilot program will be published by April 12th, with additional laboratories added to the list as they become accredited. Laboratories must complete a two-step process to become ASCA-accredited, which includes: 1) accreditation for conformity with the requirements of ISO/IEC 17025 and additional ASCA pilot program specifications; and 2) submit a request to the FDA to obtain ACSA-accreditation.
The report offers insight into trends related to complaints regarding robocall over a nearly six-year period from January 2015 through November 2020. Informal consumer complaints increased dramatically during the first four years covered by the report, from just over 200,000 in 2015 to more than 300,000 in 2018. But total consumer complaints then dropped significantly in the following two-year period, with 272,000 complaints filed in 2019 and an estimated 200,000 in 2020.
The drop in consumer complaints in 2019 and 2020 coincides with major actions undertaken by the FCC’s Enforcement Bureau against robocall operators. The Commission issued three Notices of Apparent Liability for Forfeiture during that two-year period, with proposed forfeitures totaling nearly $250 million.
The Commission also issued two Forfeiture Orders in 2020, assessing penalties of nearly $50 million in connection with almost two and half million illegal telemarketing calls.
Posted to the FDA’s website last week, the device shortage list identifies more than 20 different medical devices for which limited supplies are currently available. The list includes a variety of ventilators and ventilator systems, specimen collection systems and devices, and personal protective equipment. The FDA says that it intends to continually update its device shortages list for the duration of the COVID-19 public health emergency.
The FDA cautions that the listing of a given device on the device shortages list does not necessarily indicate that patient care has been impacted by the shortage. However, it is publishing the device shortages list is part of its broader effort to “ensure that patients and health care providers have timely and continued access to high-quality medical devices.”
It seems that the demand for computers and other electronic devices needed to support our new work-from-home population has increased to a record level. In fact, retail sales of electronics reportedly soared to a record $442 billion in 2020, with strong growth projected well into 2021.
But each of these devices requires a variety of semiconductor technologies, from central processing chips for computers to smaller, less expensive chips that control displays, peripherals, and communications devices. So, even with all-out efforts to increase semiconductor production, the overwhelming demand has forced suppliers to prioritize who gets the much-needed technology.
But the impact is also being felt closer to home (literally!), as Sony has said that the shortage of PlayStation 5 game consoles is due to the chip shortage.
Rosenworcel, who joined the FCC in May 2012, takes the helm of the agency following the departure of Ajit Pai, the former FCC chair. Pai resigned his position effective on January 20th, the day of President Joseph Biden’s inauguration as President of the U.S.
According to a press release issued by the FCC, Rosenworcel has been a leader on spectrum policy and has continually sought ways to support the broad range of wireless services. She has also championed the work of women who have impacted digital life in the 21st Century through her podcast series “Broadband Conversations.”
Prior to her time at the FCC, Rosenworcel served as Senior Communications Counsel for the U.S. Senate Committee on Commerce, Science, and Transportation. Before that, Rosenworcel practiced communications law in Washington, D.C.
According to a posting on the website of Health ITSecurity, the agency has named Kevin Fu, an associate professor of electrical engineering and computer science at the University of Michigan, to the position. Fu is also the founder and chief scientist of the Archimedes Center for Medical Device Security.
The Medical Device Cybersecurity Director post falls under the scope of the FDA’s Center for Devices and Radiological Health (CDRH) and has responsibility for leading the agency’s efforts to ensure the safety and effectiveness of medical devices against cyber threats.
The Acting Director position at the FDA is intended as a 12-month position. During his tenure, Fu will reportedly continue his roles at the University of Michigan and the Archimedes Center.