Tag Archives: medical devices

​​​​​​​Cybersecurity in Medical Devices

Photo of Lee H. RosebushPhoto of Lynn SessionsPhoto of Laura MacherelliPhoto of Eric MorrisBy Lee H. Rosebush, Lynn Sessions, Laura Macherelli and Eric Morris on Posted in Alert
smart doctorThe U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act,” stresses the critical need for manufacturers to address … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
CBO Score of House Health Bill Set for This Week Congress’s official budget scorekeepers this week will release analysis of the House-approved bill repealing most of the Affordable Care Act (ACA), and that data will inform Senate Republicans on a path for passing their version of the legislation. The Congressional Budget Office (CBO) and the … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
Senate Panel OKs FDA User Fees Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after the Memorial Day recess. The Senate HELP Committee approved the five-year renewal on a 21-2 vote. … Continue Reading

21st Century Cures: Ambitious Medical Innovation Bill Has Broad Focus

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Lindsay Holmes and Allison Rochford on Posted in Uncategorized
In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House Energy and Commerce Committee Chairman Fred Upton (R-MI), the Cures Act primarily overhauls the FDA’s drug and device … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
New Bill Targets Drug Prices Bipartisan legislation introduced in the Senate last week would require pharmaceutical manufacturers to alert the U.S. Department of Health and Human Services (HHS) before increasing prices more than 10 percent, continuing congressional pressure on the industry over drug pricing. The bill’s authors – including Sen. John McCain, (R-AZ) – say … Continue Reading

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

Photo of Lance L. SheaPhoto of Joel D. GottesmanBy Lance L. Shea and Joel D. Gottesman on Posted in Uncategorized
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The guidance, titled Postmarket Management of Cybersecurity in Medical Devices (Postmarket), is intended to clarify the FDA’s recommendations and emphasize the importance of monitoring, identifying, … Continue Reading

House Passes 21st Century Cures Act

Photo of Lance L. SheaBy Lance L. Shea and Nita Garg on Posted in Uncategorized
On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st Century Cures Act” (Cures bill), is to accelerate the drug development process by reducing or removing regulatory obstacles. Specifically, … Continue Reading

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care Management Association’s (PCMA) opposition to the legislation is not about the content of the bill but rather how Congress intends to pay for it. The 21st … Continue Reading

21st Century Cures Act Passes House Committee

Photo of Lance L. SheaBy Lance L. Shea and Nita Garg on Posted in Uncategorized
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark medical innovation” bill, key provisions of the Cures bill are intended to speed marketing approval of drugs and medical devices. … Continue Reading
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