Advamed - Articles - Page 4

US FDA says it will inspect independent medical device servicers

May 9, 2024

The U.S. FDA finalized a guidance for third-party servicing of medical devices, which helps to clarify the distinction between servicing and remanufacturing of a device. However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on these entities.

WTO steps back from renewal of IP waivers for COVID

March 6, 2024

By Mark McCarty

The World Trade Organization wrapped up its 13th ministerial conference and, as the saying goes, no news is good news. Life science trade associations in the U.S. lauded the end of the conference without an extension of intellectual property rights waivers for therapies and diagnostics for the COVID-19 pandemic, although this outcome was not entirely surprising.

U.S. at night from space with circuit board overlay

FDA staff can access management meeting notes in QMSR final rule

Jan. 31, 2024

By Mark McCarty

The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.

Advamed wary of government plan to privatize US helium depot

Jan. 23, 2024

By Mark McCarty

Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.

FDA expands definition of in silico trials in computational modeling final

Jan. 18, 2024

By Mark McCarty

Sometimes a small change of wording has a big effect on the implications of a U.S. FDA guidance, a notion that may apply to the U.S. FDA’s final guidance for the use of computational modeling in device premarket submissions.

US Congress, courts provide push, pull on EPA ethylene oxide rulemaking

Oct. 25, 2023

By Mark McCarty

The U.S. Environmental Protection Agency (EPA) has struggled to devise a final rule regarding regulation of ethylene oxide (EtO) after several years, a regulatory activity that has device makers concerned about domestic capacity for sterilization.

2023 Med Tech Conference

PCCP concept at risk of being subsumed in debate over artificial intelligence

Oct. 10, 2023

By Mark McCarty

The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.

2023 Med Tech Conference

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

Oct. 10, 2023

By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.

Bipartisan momentum gathering for reforms of US Medicare program

Sep. 20, 2023

By Mark McCarty

The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.

Bipartisan momentum gathering for reforms of US Medicare program

Sep. 19, 2023

By Mark McCarty

The U.S. Centers for Medicare & Medicaid Services (CMS) is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.