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FDA finalizes guidance on “Remanufacturing” vs “Servicing”

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to...more

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical devices. The final rule...more

FDA expands inspection obstruction guidance to apply to device facilities

The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection,” which, if finalized, would expand...more

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

FDA takes action to reduce surgical mask shortage

To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable,...more

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more

FDA to restart domestic inspection program using new Advisory Rating system

The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The agency had temporarily halted most...more

FDA takes significant action to reduce mask and respirator shortage

To address the increased usage and shortages of respirators as a result of combatting COVID-19, on 24 March 2020 the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for non-NIOSH approved...more

FDA moves to increase ventilator supply

Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020,...more

COVID-19: Daily Report for Life Sciences and Health Care Companies

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

FDA temporarily postpones all domestic routine facility inspections in response to COVID-19 pandemic

On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic routine surveillance facility...more

EU sets out restrictions on export of certain personal protective equipment

The EU has imposed restrictions on exports of certain personal protective equipment (PPE), whether originating or not in the European Union, in response to the COVID-19 outbreak....more

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

FDA delays draft rule for QSR/ISO 13485 harmonization

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020. This is the second delay in the agency's...more

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

FDA issues final guidance for public warnings and notification of recalls

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for...more

MDR single report exemption and ASRs: Coming to an end for most reporters

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and monitor adverse events (deaths,...more

FDA releases final guidance document on PMA manufacturing site change supplements

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

Regulatory Insights for Life Sciences and Health Care Investments: Medical Device and Technology

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

CDRH's Voluntary Malfunction Summary Reporting Program

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more

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