Michele Buenafe on Manufacturers

FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance

While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for...more

5/22/2024 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

AI in Medical Devices and Healthcare: Opportunities, Challenges, and What Lies Ahead

In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more

3/9/2023 / Artificial Intelligence , CDRH , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Manufacturers , Medical Devices , Pharmaceutical Industry , Popular

FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...more

1/19/2022 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry

The PREP ACT: Critical Liability Immunity for Critical Products

As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products. ...more

7/29/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Immunity , Manufacturers , Material Suppliers , Medical Supplies , Pharmaceutical Industry , Public Readiness and Emergency Preparedness Act (PREP Act)

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

4/5/2020 / CARES Act , Coronavirus/COVID-19 , Drug Distribution , Federal Loans , Financial Stimulus , Food Manufacturers , Manufacturers , Medical Devices , Pharmaceutical Distribution , Pharmaceutical Industry , Prescription Drugs , Relief Measures , Small Business , Suppliers

COVID-19: Transforming Your Manufacturing Operations to Supply Critical-Need Medical Devices

The White House is reportedly in discussions with US auto companies to aid in the coronavirus (COVID-19) relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make...more

3/22/2020 / Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , New Guidance

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

2/14/2017 / Cybersecurity , Food and Drug Administration (FDA) , Labeling , Life Sciences , Manufacturers , Medical Devices , Obama Administration

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

1/10/2017 / Cybersecurity , Data Breach , Final Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

10/4/2016 / 510(k) RTA , Draft Guidance , FDASIA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Modification , Risk Management , Section 510

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

6/15/2016 / Comment Period , Data Collection , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Information Sharing , Manufacturers , Medical Devices , Patient-Specific , Privacy Policy

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

5/20/2016 / 3D Printing , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

2/10/2016 / Adverse Events , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

2/3/2016 / Comment Period , Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Risk Management

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

10/30/2014 / Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Product Enhancements , Product Recalls

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

8/26/2014 / FDASIA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

7/23/2014 / Draft Guidance , Final Guidance , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Marketing , Medical Devices , Unique Device Identifiers

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

7/16/2013 / Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Reporting Requirements

Final Sunshine Act Arrives: Now the Hard Part

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

3/8/2013 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Healthcare , Manufacturers , Medical Devices , Pharmaceutical Industry , Physicians , Reporting Requirements , Sunshine Act

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