January 19, 2022
The U.S. Department of Justice has recently announced several actions in connection with alleged clinical trial fraud, but going forward, this point of emphasis will not be incidental for federal...
January 19, 2022
The U.S. Food and Drug Administration (FDA) released a new guidance document on January 11, 2022 titled “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device...
January 10, 2022
During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) felt pressured to expeditiously authorize new medical devices that could protect the public. Medical equipment such as...
January 3, 2022
The Centers for Medicare & Medicaid Services has formally scuttled its proposal to cover breakthrough medical devices, but recent developments have breathed new hope into the Medicare Coverage of...
December 21, 2021
The FDA has published a draft guidance that explains the agency’s authority to destroy counterfeit devices, an authority the agency did not enjoy until passage of the Safeguarding Therapeutics Act of...
December 15, 2021
Brexit has given regulatory bodies in the United Kingdom (UK), such as the Medicines and Healthcare products Regulatory Agency (MHRA), great freedom. They are using that freedom to pave the way for...
December 8, 2021
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed to overhaul its regulatory framework for medical devices that will span all medical technologies. The...
November 19, 2021
The U.S. Food and Drug Administration (FDA) has come together with other international Public Health counterparts to outline a set of ten guiding principles related to medical devices that use...
November 17, 2021
The CARES Act, signed into law on March 27, 2021, is aimed at managing the COVID-19 crisis and moderating its economic impact. Section 3112 of the CARES Act enabled FDA to avoid drug shortages by...
October 21, 2021
In October 2021, the Medical Device Coordination Group (MDCG) published a guidance to aid medical device manufacturers in complying with classification rules in the European Medical Device Regulations...
