Policy – media

UK Government announces prescription price hike to record level

The UK Government has announced plans to increase prescription charges by 20p, or 2.3%, to a record £8.80, effective 1 April.
- Source: pharmafile
- 530
- February 28, 2018
NHS Policy prescription charges
CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases

On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
- Source: National Law Review
- 696
- February 23, 2018
CFDA medical device Policy
FDA steps up efforts at bringing about medical device cyber security

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cybersecurity is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.
- Source: COMPLIANCE4ALL14
- 648
- January 31, 2018
cybersecurity FDA medical device Policy
NHS launches online care plan to empower end of life patients

The NHS has launched a service that allows patients to share their urgent and end of life care wishes.
- Source: Digital Health Age
- 613
- January 31, 2018
digital health end of life healthcare NHS Policy
FDA to expedite release of recall information

When the FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak.
- Source: Mass Device
- 662
- January 22, 2018
Consumer Healthcare FDA Policy
3D Printing Goes Legit with FDA Guidance

The FDA guidance does give potential 3D medical device manufacturers a path to follow to prepare for FDA approval.
- Source: HealthTech Insider
- 630
- January 18, 2018
3D printing FDA medical device products Policy
UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

Recent guidance from UK medical device market regulators on human factors engineering (HFE) includes some recommendations that differ from HFE requirements established in Europe, suggesting a more standalone British approach to some areas of device development.
- Source: Emergo
- 595
- January 15, 2018
FDA medical device Policy
4 Ways to Reduce EHR Use-Related Patient Safety Threats Widespread EHR use increases the potential for patient safety risks to occur, so providers must prepare accordingly.

A study released in October 2017 found EHR (electronic health records) use has been listed as a contributing factor to patient injury at an increased rate over the past decade. Poorly-designed EHR systems combined with human error have resulted in patient safety problems in an increasing number of malpractice claims from 2007-2016.
- Source: Xtelligent Media
- 509
- January 5, 2018
EHR health IT healthcare technology Policy
FDA suggests controls on interoperable devices

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
- Source: massdevice
- 573
- December 14, 2017
FDA interoperable medical device Policy
Gottlieb Announces More Regulatory Updates to Encourage Device Innovation

Less than a week after announcing 3 new guidance documents to streamline the review of digital health, the FDA is moving to refine its 510(k) medical device approval pathway.
- Source: hcanews
- 522
- December 12, 2017
digital health medical device Policy

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