Postmarket Compliance and Enforcement Actions

Representative experience

We establish regulatory training programs to educate internal units of major medical device and combination product companies about adverse event reporting requirements and procedures.

We have assisted clients in responding to enforcement actions related to inadequate adverse event reporting and helped develop procedures to protect against future enforcement.

Helped clients conduct retrospective reviews of their files to assess their obligations in submitting Medical Device Reports to the FDA and bring their reporting up to date.

News

FDA issues new policy for evaluating impact of viral mutations on COVID-19 tests

24 February 2021

The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The...

News

The European Commission issues guidance concerning management of legacy devices in EUDAMED

18 February 2021

On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices ...

News

Biden Issues wide-ranging Buy American Executive Order – FAR rulemaking to come

26 January 2021

On 25 January 2021, President Biden issued his first Buy American Executive Order (EO), titled Ensuring the Future Is Made in All of America by All of America’s Workers, which is...

News

HHS proposal to exempt medical devices from 510(k) process halted

22 January 2021

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the...

News

Five highlights from FDA’s new AI device regulation Action Plan

15 January 2021

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part...

News

Remote QMS audits under the MDR are finally allowed by the European Commission

13 January 2021

On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and ...

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