FDA - Methodsense, Inc

FDA Issues New List of 510(k) Exempt Medical Devices

New Class II 510(k) Exempt Medical Devices As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and...

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital...

February 21, 2017
By Rita King
IEC 62304, Life Science Software, Risk Management

Cybersecurity’s Impact on Health Systems

We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient....

December 14, 2016
By Rita King
FDA Compliance, Medical Devices

Obama Signs the 21st Century Cures Act into Law

21st Century Cures Act into law. Most of what people will be hearing from the media will be focused on the Act’s support of cancer research, mental health policies, brain research to tackle diseases like Alzheimer’s and the funding allocated for these initiatives. However, the 996-page bill also includes major changes that impact the way...

April 11, 2016
By Rita King
Risk Management

What Happens When the FDA says, “I don’t know”

The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to...

Laboratory Developed Tests for Medical Devices

FDA Oversight of Laboratory Developed Tests (LDTs) is on the Horizon

How Do Laboratory Developed Tests Impact Your Business? The Office of Public Health Strategy and Analysis recently issued a report that reviewed 20 products that relied on Laboratory Developed Tests (LDTs) to determine whether a lack of oversight may have caused actual harm to patients or not. Once, LDTs were relatively simple tests that may not...

Improving FDA Reviews of Combination Products

Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report that provided recommendations on how the FDA could improve reviews of combination products. Combination products include: Products comprised of two or more regulated components, such as drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically,...

FDA Issues Final Guidance on Reusable Medical Devices

Endoscopes Linked to “Superbugs” Lead to New FDA Guidance for Reusable Medical Devices UPDATE The FDA has released the slides from their presentation on Reprocessing Medical Devices. Get the slides here. In light of the fatal “superbugs” that have been plaguing hospitals after using endoscopes, the FDA has released new guidance for reusable medical devices....

February 9, 2015
By Rita King
FDA 21 CFR Part 11, FDA 21 CFR Part 820, FDA Compliance

Meet FDA Requirements

Meet FDA Requirements for Medical Device Company Compliance Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations...

August 9, 2012
By Rita King
FDA Compliance, Quality Management, Risk Management

Tag: FDA