FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

The US Food and Drug Administration plans to add two more product areas to its ongoing Total Product Life Cycle Advisory Program (TAP), the agency announced on 1 July.

More from Regulation

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Rapid Action Required For Medtech Compliance With EU Batteries Regulation

 

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

Urgent Call for Leadership In EU Medtech To Steer Through Regulatory Challenges

 

EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.

More from Market Access

Prostate Cancer Research Urges UK To Implement Screening Program Without Delay

 

Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.

Philips Partners With Three Health Insurance Providers To Remotely Monitor High-Risk Pregnancies

 

Several counties in the US state of Georgia are maternity care “deserts.” Remote monitoring of high-risk pregnancies with maternal hypertension and diabetes could help improve the state’s high rate of maternal mortality, according to leading health service provider Philips.

Medtronic Widens Parkinson’s aDBS Opportunity With Key US Approvals

 

Medtronic’s US FDA approval for BrainSense aDBS and BrainSense EI software features of the Percept neurostimulator device has quickly followed CE marking in January.