The U.S. House of Representatives has passed a stopgap spending bill by a vote of 343-67 to fund federal government operations for a week in order to allow both chambers to arrive at an overall spending bill for the remainder of fiscal year 2021. H.R. 8900, introduced Dec. 8 by Rep. Nita Lowey, resumes funding for agencies such as the FDA through Dec. 18, but the additional week of federal agency funding must be met by negotiations over COVID-19 pandemic relief legislation in addition to a final sign-off on the balance of the FY 2021 budget. A bipartisan coalition of House and Senate members are pressing the case for a $908 billion stimulus plan that includes controversial liability protections for businesses and other organizations, as well as additional monies for the Paycheck Protection Program. Other monies found in the stimulus plan would be applied toward distribution of vaccines for the pandemic, as well as testing and contact tracing. H.R. 8900 is available for a vote in the Senate, but must be signed by President Donald Trump by midnight Dec. 11 in order to avert a government shut-down.
Senate passes counterfeit device destruction bill
The U.S. Senate has passed H.R. 5663, the Safeguarding Therapeutics Act of 2020, which would allow the FDA to destroy counterfeit medical devices. The bill was introduced to the House Jan. 21, 2020, and provides the originating source of the devices an opportunity to appeal any stated intent to destroy the violative product. H.$. 5663 was agreed to Sept. 21 in in the House by voice vote, and agreed to by unanimous consent in the Senate Dec. 8. The legislation was prompted largely by concerns regarding products shipped to the U.S. in connection with the COVID-19 pandemic.
The House also passed by voice vote H.R. 7898, which would provide a technical correction to Title XXX of the Public Health Services Act relating to investigations of information blocking. The bill was introduced by Rep. Michael Burgess (R-Texas) and would allow the Office of Inspector General at the Department of Health and Human Services to obtain information and assistance from other federal agencies when investigating allegations of information blocking on the part of developers/deployers of health information technology. As currently written, the bill’s effective date would be presumed to be the date of enactment of the 21st Century Cures Act, which was Dec. 13, 2016.
MHRA posts device compliance dates for Brexit
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) posted a set of guidelines for placing medical devices in the British market, noting at the outset that any devices bearing a CE mark will be recognized by MHRA until June 30, 2023. Any certificates issued by notified bodies certified by the European Union will also be recognized through that date, after which the EU member states will no longer recognize certificates issued by NBs certified by MHRA. Despite that the agency will continue to recognize existing device certifications through June 2023, device makers will be able to access premarket review programs as of Jan. 1, 2021. The compliance date for registration is sooner, however, effective Jan. 1, 2021, although a grace period of May 1, 2021, will be applied to class III and class IIb active implanted devices, while the grace period for other class IIb and class IIa devices is Sept. 1, 2021. The registration deadline for class I devices is Jan. 1, 2022.