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
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first...more
The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing...more
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
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
2/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Telemedicine
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
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. The de novo process allows FDA to establish new product classifications for low- to...more
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more
4/14/2021
/ Artificial Intelligence ,
Data Protection ,
Digital Health ,
Exclusivity ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Software ,
Supervision and Collaboration Agreements
In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed...more
2/8/2021
/ 510(k) RTA ,
Biden Administration ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Pre-Market Notification ,
Premarket Approval Applications ,
Regulatory Reform ,
Regulatory Requirements ,
Safety and Performance Pathway
Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
1/8/2021
/ Biden Administration ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Digital Health ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more
12/30/2020
/ Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Public Health Emergency
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more
The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and...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
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 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
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