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Final Rules › Reporting Requirements › Medical Devices

Epstein Becker & Green

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Epstein Becker & Green on

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Blake, Cassels & Graydon LLP on

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Faegre Drinker Biddle & Reath LLP

FDA's Final Rule for Laboratory Developed Tests

Faegre Drinker Biddle & Reath LLP on

The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar on February 25, 2025, from 2:00 p.m. EST to 3:00 p.m. EST, providing additional information...more

Gardner Law

CMS Auditing Companies for Sunshine Compliance: Are You Ready?

Gardner Law on

As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more

Baker Donelson

Medicare Spreads Sunshine Act Coverage to New Categories of Payments, Recipients

Baker Donelson on

On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more

Stinson - Government Contracting Matters

Final FAR Rule Mandating GIDEP Reporting of Actual or Suspected Counterfeit Parts Issued: More Questions Than Answers

Stinson - Government Contracting Matters on

Supply chain risks are on the rise. Protecting the supply chain is a critical aspect of our national security, health and public safety. Whether parts are electronic or not, if they aren’t what they are represented to be,...more

Arnall Golden Gregory LLP

FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule

Arnall Golden Gregory LLP on

The Food and Drug Administration issued a final rule setting forth postmarketing safety reporting (PMSR) requirements for combination products subject to premarket review by FDA on December 20, 2016. For some of these...more

Stinson LLP

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

Stinson LLP on

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

Mintz - Health Care Viewpoints

CME Payments Largely Remain Excluded From Sunshine Act Reporting

Mintz - Health Care Viewpoints on

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

Sheppard Mullin Richter & Hampton LLP

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

Sheppard Mullin Richter & Hampton LLP on

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

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