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
These seven key provisions will affect the premarket requirements for medical devices.
The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law....more
New legislation includes a broad regulatory exemption for medical software.
On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more
FDA’s proposed adoption of an IMDRF document raises questions.
On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD): Clinical...more
The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens.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
The Agency shows no signs of slowing regulatory activity.
Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
9/1/2016
/ Advisory Committee ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Diagnostic Tests ,
Enforcement Actions ,
Final Guidance ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Investigational Device Exemptions ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient-Specific ,
Provider Payments ,
Unique Device Identifiers ,
Validity
The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services.
On July 29, the US Food and Drug Administration (FDA) announced the...more
The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests.
On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more
Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more
FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies.
Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more
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
The new interactive tool highlights the relevant federal regulatory schemes, but the high-level analysis may limit its value to mobile health app developers....more
Additional guidance documents are expected.
The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more
The guidance documents relate to human factors testing, data, and clinical considerations.
The US Food and Drug Administration (FDA or the Agency) had a busy month in February with respect to human factors, issuing three...more
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
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
As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more
7/27/2015
/ Biotechnology ,
Digital Health ,
Electronic Medical Records ,
FCC ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Hospitals ,
Marketing ,
Medical Devices ,
Patient-Specific ,
Premarket Approval Applications ,
Software Developers ,
State Regulators ,
Sunshine Act ,
Telemedicine
The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices.
In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more
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