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
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more
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
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
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
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
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
3/13/2020
/ China ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Crisis Management ,
Diagnostic Tests ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Inspections ,
Life Sciences ,
Marketing ,
Medical Devices ,
New Guidance ,
Personal Protective Equipment ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Supply Chain ,
Warning Letters
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
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
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
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
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
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
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 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
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
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
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
Agency also launches voluntary pilot program as first step in developing software pre-certification program....more
The law would prohibit most gifts to healthcare professionals and providers....more
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
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
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
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
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
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