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Medical Devices › Third-Party

Knobbe Martens

FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs

Knobbe Martens on

Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties.  The Food and Drug Administration’s (FDA) Center for Devices and...more

McDermott Will & Emery

The Tale of Two CE Programs: OIG Compares Healthcare Provider and Third-Party Continuing Education in Recent Advisory Opinion

McDermott Will & Emery on

The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 2 – The Bribery Schemes

Thomas Fox - Compliance Evangelist on

After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more

Smart & Biggar

Rx IP Update - January 2019

Smart & Biggar on

IN THIS ISSUE: -Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative - PMPRB News: **PMPRB issues a Notice of Hearing for allegations of excessive...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Thomas Fox - Compliance Evangelist on

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Arnall Golden Gregory LLP

FDA Issues Draft Guidance on 510(k) Third Party Review Program

Arnall Golden Gregory LLP on

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to...more

Morgan Lewis

International Life Sciences Data Transfers After Schrems

Morgan Lewis on

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

Foley Hoag LLP

Product Liability Update - April 2013

Foley Hoag LLP on

In This Issue: - United States Supreme Court Holds Class Certification Improper Absent Showing Plaintiffs’ Damages Can Be Measured on a Classwide Basis through Use of a Common Methodology that Is Consistent with...more

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