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
Agency also launches voluntary pilot program as first step in developing software pre-certification program....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
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
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
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
Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....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
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
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
On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more