When completing your 510(k) clearance submission for FDA approval, you will be required to demonstrate that your device is both safe and effective. According to the rules and regulations of submitting a 510(k), the FDA states that you can prove the effectiveness and safety of your product by proving its substantial equivalence to an existing legally marketed device, otherwise known as a predicate device.

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What is a Predicate Device?

The predicate device must have been legally marketed before 28^th May 1976 and obviously pre-approved by the FDA. According to Device Watch, when submitting your 510(k), you must accurately compare and associate the similarities between your device and that of your predicated device. The devices do not have to be completely identical to each other, but rather, they must share similar aspects such as intended use, energy used, deign, performance, standards, labelling, effectiveness, safety and other relevant characteristics.

How to Find a Predicate Device

Finding a suitable predicate device is usually the stage of the 510(k) submission that most applicants dread. However, it is actually quite simple to find one since the FDA owns a huge database that contains a list of previously cleared 510(k) devices and this list is constantly being updated. To find which of these devices is suitable, you must take your product code and search for it in the Product Code Classification Database. This will then bring you to your specific classification of your device and you will be given a list of similar device types previously cleared by the FDA 510(K). You can also search for manufactures names, devices and other search terms to find a suitable predicate device to your own.

510(k) Clearance Guidance

People are easily intimidated by 510(k) clearance. It seems like a mountain of a task and one better left to the professionals. A huge drawback is the sheer amount of time it takes to have your submission cleared by the FDA. This process can take months to complete. To avoid the long queue of stacked 510(k) submissions, it’s probably a better idea to choose an Accredited Persons to help instead. These are FDA approved companies to help with FDA 510k Clearance submissions. Third Party Review companies such as fdathirdpartyreview are able to review your submission and forward their findings to the FDA. This works out to be a lot less time consuming because the FDA are obligated to respond with their final decision within 30 days.

Following the completion of research studies carried out by Clinical Research Associates from professional clinical solution providers such as http://www.gandlscientific.com, new medical treatments and technologies must be approved by the FDA before they can be marketed in the U.S. This process can take months and many of these treatments are rejected if they are not proven to be both safe and effective for human use. Continue reading 4 Shocking Medical Devices Approved by the FDA →

Traditional formal wedding photography is losing touch with today’s brides and their grooms. Today the fashion is for much more informal unstaged pictures – candid photography. Many couples like it because it captures more realistically the emotions of the day and what everyone is really feeling, and that’s what they want to remember about their special day. Continue reading Candid Cameras Are the New Thing for Modern Weddings →

There was a time when all commercial kitchens were situated behind closed doors and customers couldn’t see what was going on. However, there is now a growing trend for new restaurants to have an open plan layout, where the kitchen is visible from the dining area. What benefits can this bring for both the business and the customers? Continue reading Why are more restaurants choosing open plan? →

Today, smartphones are not a luxury item – they are something that is so common that even a lot of schoolchildren own them. They are also rapidly becoming the preferred way of using the web for a lot of adults.

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This means that every business owner should make an effort to cater to mobile users. In fact, comScore reports that we have reached the point where there are more mobile web users than there are desktop users, and as Smart Insights explains in their report, this means that having a good strategy for reaching and retaining mobile users is essential. The good news is that you don’t need to have different websites for desktop and mobile users if you take advantage of responsive designs.

One Site, Many Platforms

Neilsen offers some useful guidelines for “transmedia” websites. These guidelines cover the points that every website should hit – things like catering to slow download speeds, old software, weak hardware, touch interfaces and unusual screen resolutions. Responsive design covers most of these issues quite well, so if you use a good CMS and choose a theme that covers mobile and desktop devices then you are already ahead of the crowd.

Companies such as https://www.bugfinders.com offer software testing services that have those crucial cross-platform optimisations in mind. They understand that the days of there being a difference between a mobile and a desktop website are long gone. With the exception of perhaps serving up lower quality, smaller images for low resolution screens, websites should be fluid and have layouts that look good on any device.

If you are looking for a software testing company, make sure that they understand how to provide a good end-user experience for both desktop and mobile users, and make sure that they test their websites on as many different platforms as possible. Do not make assumptions about how your website will look – remember that while many smartphones have sophisticated browsers, when you get to the lower-end feature phones, things become far more unpredictable in terms of functionality and power.

Looking to The Future

The trend towards “Phablets” may change the design constraints that web designers face when it comes to accommodating mobile users, but right now there are a huge number of different screen sizes, and browser capabilities, for designers to consider. If you want your site to succeed, then you cannot afford to ignore any of your user-base.

Today, a “normal website” should be a flexible, powerful website that looks good whether it is viewed on an iPad with a retina display, a feature phone, a tablet PC or an old desktop using Internet Explorer (after all, you want to cater to people shopping at work!) if you cannot do this, you will lose customers. Given the power and flexibility of modern content management systems, and the fact that Google is pushing webmasters to be more mobile-friendly, it makes sense to invest in improving your site today.

With more requirements than ever before for safe and efficient refrigeration, pharmaceutical and food companies are feeling the heat when it comes to managing refrigerated freight. Both sectors are being pressurised to ensure that the cold chain is meeting quality standards in terms of temperature control, energy dependence and regulatory requirements.

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As a result, more and more research is being ploughed in to the industry, leading to some key trends which look set to improve logistics and achieve efficiencies.

Current Trends in the Cold Chain

As consumer demands grow more complex, there has been a recent shift towards globalization. For example, with tastes for products such as Alaskan salmon becoming more mainstream, firms have had to swiftly amend their outlook to accommodate ways of sourcing and shipping foodstuffs and pharmaceuticals safely across extended distances. VersaCold report this demand is prompting innovation, with transit control a priority.

This shift in consumer expectations has also impacted cold chain commitment to maintaining refrigerated warehouses across up to five disparate temperature zones. To avoid the inevitable changes to taste and texture through fluctuations in temperature, firms are battling to maintain consistency as well as safety, speed and quality. There is also a move towards temperature-assured reefers and other containers to accommodate increased sensitivity for pharmaceuticals which need to be shipped at consistent levels.

Increasing Demands on Commercial Refrigeration

Directives issued by the European Union on distribution of medicinal products in 2013 called for manufacturer-established recommendations to be observed not just in storage, but across the entire transportation process. The coverage also applies to over-the-counter medicines. This mandate has greatly increased the demands for consistency across the entire shipping of products.

Strategically, firms are now considering positioning of suppliers across the flow of goods to ensure they are able to accommodate the new quality requirements. This means considering speed, consistency, location and capabilities in addition to cost-effectiveness. For example, Nestlé Canada has adopted Lean principles to ensure quality can be managed in addition to maintaining cost effectiveness, while https://www.fridgefreezerdirect.co.uk/ commercial refrigeration experts are seeing much more demand for high-quality, highly compliant solutions.

While industry regulation and increased quality is positive for consumers, these trends are placing increasing pressure upon the cold chain industry. Only those firms committed to considering innovative solutions will maintain compliance while remaining cost-effective.

Students have had it tough financially following the introduction of tuition fees, and an increasing move towards experience-based attributes over academic prowess.

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A recent refusal by the government to honour a petition to axe a retrospective hike in student loan interest rates has added to the challenges faced by many young academics.

The petition, which was launched by Durham student Alex True, generated over 120,000 signatures over the course of just a few days. However, despite overwhelming support for the petition, the Department for Business, Innovation and Skills turned down the request, suggesting that an alternative approach to repayment thresholds would undermine the equality of the student support system, whereby all students can access a university education, regardless of financial standing or ability to pay back loans. The statement suggests that the government are remaining firm in their decision to freeze the repayment threshold to maintain a unified student support system.

The BIS continued by confirming that applications for university admission by disadvantaged young people is at a record high, and taxpayers need some way of managing this increase.

Increasing the Need for IVA Debt Management

In 2010, the government stated a promise that as of April 2017, the repayment threshold for all student loans would rise each year, in line with average earning rates. Alex True’s petition focused on the fact that the government has now backtracked on this statement, by freezing the threshold at £21,000. This means that all graduates will now have to pay more for their student loans.

BIS stated that the petition was considered carefully prior to the decision being made to reject the request. The decision was made, they said, as a result of considering the wider socio-economic impact of a repayment threshold which rises to reflect national rates of inflation and average earnings.

The decision is increasing the difficulties many students face in repaying student loans, leading to a number of graduates turning to https://www.carringtondean.com/individual-voluntary-arrangement-iva/ Individual Voluntary Agreements to manage their debts, to ensure that they can repay loans.

‘Disappointed and Disheartened’

In response to the decision, campaigner True has stated that he feels disappointed and disheartened with the response, which did not address the issue that a retrospective change to the existing loan agreement without mutual consent from all parties was unethical.

Having multiple trusts with each below the IHT limit of £325,000 has been a popular trust planning strategy for some time. While there are no tax savings to be had initially, the effect is that you can reduce the tax charge every ten years when tax is due and also reduce the exit charge. Continue reading Do discretionary trusts have a role to play in tax mitigation? →

Running your own netball centre is an exciting prospect. You may be setting up new teams within your district or feel you deserve better facilities than those presently on offer. You have a few choices when it comes to financing your new venture. You can buy outright, lease the ground or look into running a franchise.

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The most important thing is to get the location right so that players can easily access the site. Then you can decide whether you want to buy the land or rent it. Owning outright is the best option if you can afford it because you’ll have more choice in terms of what to build. You also won’t face the prospect of your landlord giving you notice to quit.

Shop around for finance

It should be possible to borrow the money from a private investor or bank loan, but shop around for the best deal and talk to several different financial institutions. Rather than building new, you may find there are existing sports centres for sale that just need a little work instead of starting from scratch. This could be something your local authority could help you explore.

You may want to rent part of an existing sports complex or find a property owner with a spare plot of land who is willing to lease it to you. Make sure a proper contract is drawn up so you know who pays for the upkeep.

Start a franchise

There is a third option of running a franchise, which could be a quicker way to set up netball sessions and leagues in your area. The advantage is that you will have the franchisor’s proven business formula and marketing skills to fall back on, but you may have to pay a management fee, which could put it out of reach financially.

Once you have opened your netball centre and attracted players, you will need to make sure that enough of them return every time so you can set up a team and keep a decent cash flow. There are many netball drills you can incorporate into training to improve players’ skills in all areas. You can find examples at http://www.sportplan.net/drills/Netball/drills.jsp.

You could also perform an online search for other netball business owners to find out their financing experiences and long-term forecasts.