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Staying Within the Legal Lane: Providing Products and Services for COVID-19

Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more

Inspections Remain on Hold; FDA Collaborates with CDC to Develop a Process to Resume Program

Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

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

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

FDA Suspends Routine Domestic Drug and Device Inspections Due to COVID-19

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more

FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document...more

FDA Goes Back to the Drawing Board on Clinical Decision Support Software

In its new draft guidance document on clinical decision support (CDS) software, the US Food and Drug Administration revamps its proposed interpretation of the 21st Century Cures Act and proposes new policies of enforcement...more

Life Sciences International Review - Q2 2019

EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

FDA Issues Proposal on Oversight of Artificial Intelligence and Machine Learning Software

The Food and Drug Administration’s recent discussion paper suggests a new regulatory approach for evaluating postmarket changes to artificial intelligence and machine learning software devices, but further clarity is needed...more

FDA Finalizes Program for Medical Device Reporting in Summary Form for Certain Manufacturers

The US Food and Drug Administration (FDA) issued an order in the Federal Register on August 17 announcing a new “Voluntary Malfunction Summary Reporting Program.” FDA issued this order to implement certain provisions of the...more

US House Votes to Repeal Medical Device Excise Tax

While the US House of Representatives recently voted to repeal the medical device excise tax imposed by a 2010 amendment to the Affordable Care Act, there is no sign that the Senate will vote on this issue any time soon. ...more

Blockchain in Healthcare Technology Could Boost Patient-Provider Information Exchange

Blockchain continues its buzz in healthcare for its potential to revolutionize patient records, medical data, medical billing, and wearable device use. Healthcare stakeholders may consider using this technology to advance...more

FDA Delays eMDR System Adverse Event Codes Update

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply....more

Moratorium on Medical Device Excise Tax Extended for Two Years

With the passage on January 22 of continuing appropriations through February 8 (HR 195), the moratorium on the medical device excise tax has been further extended until January 1, 2020, providing relief to medical device...more

What Pharma Companies Need to Know about FDA’s New Draft IVD Guidance

As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and, if working with IVD...more

FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act

Agency also launches voluntary pilot program as first step in developing software pre-certification program....more

California Bill May Upend Pharma Company Interaction with HCPs

The law would prohibit most gifts to healthcare professionals and providers....more

OCR Announces First HIPAA Settlement with Wireless Health Services Provider

The $2.5 million settlement reflects the agency’s focus on mobile health privacy. On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more

Congressional Committees Propose Restructuring of User Fees in Draft Language

The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of Representatives released a...more

New York Attorney General Settles Claims against Three Health Apps

Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more

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

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

FDA Issues Final Guidance on “Emerging Signals”

Guidance addresses industry concerns about premature public notifications. On December 14, 2015, the FDA issued a final guidance titled “Public Notification of Emerging Postmarket Medical Device Signals” (Final...more

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