FDA Pilot Project Aims at Quick Approvals for Medical Software

FDA Pilot Project Aims at Quick Approvals for Medical Software

The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to precertify the company.

"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products", said Dr. Gottlieb. Similarly Apple is now working with Stanford clinicians to research how the Apple Watch could detect abnormal heart rhythms, something that would most likely require FDA approval if it were to diagnose.

"We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate", FDA Commissioner Scott Gottlieb said in a statement reported by Bloomberg.

Officially dubbed the Pre-Cert for Software Pilot, Gottlieb at the time called it "a new and pragmatic approach to digital health technology".

Two months after outlining a precertification program to speed the approval of digital health software, the FDA has announced the 9 companies that will participate in the pilot program, which include tech industry giants, software startups, and pharmaceutical manufacturers. The pilot program will focus on looking at the software developer or digital health developer first, instead of traditionally looking primarily at the product. Apple, for example, has tended to partner with existing health researchers and companies such as DexCom Inc, a conventional medical device firm, for uses of their products that involve regulatory oversight.

As part of the program, the FDA will take a close look at Apple and the other eight companies. They may even not have to submit a product for premarket review in some cases.

"We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory framework and are proud to have been selected to participate in this innovative pilot program", Park said in a statement today. Fitbit will bring to the program its expertise in evidence-based innovation and in developing engaging experiences and tools that help motivate and inspire consumers to make behavior changes that can help improve health outcomes.

"We previously said that the digital health pilot will include nine companies".

According to the FDA, the companies will now provide the agency access to measures they currently use to develop, test, and maintain their software products, including ways in which they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and to provide information about their quality management system. The FDA wrote that it will welcome input from the pilot participants and other interested parties throughout the duration of the pilot, and plans to hold a stakeholder workshop in January 2018.

Related News:

  • Watch The 'Blade Runner 2022' Anime, Scored By Flying Lotus

    Watch The 'Blade Runner 2022' Anime, Scored By Flying Lotus

    They even used a DSLR to film this scene (I'm sure Roger Deakins , the DP, has a very good reason to do that). Practical, Practical, PracticalJust one example of the gorgeous sets " Blade Runner 2049 " utilizes.
    8 foreigners among the quake dead in Mexico City

    8 foreigners among the quake dead in Mexico City

    The quake caused new alarm in a country reeling from two still-more-powerful quakes this month that have killed almost 400 people. He said the only evidence of a possible survivor were images from a camera lowered into the rubble that showed the blood traces.
    London Southend offers free flights to passenger hit by Ryanair cancellations

    London Southend offers free flights to passenger hit by Ryanair cancellations

    A staffing blunder is thought to be responsible for the cancellations , which led to a tumble in Ryanair's share price. Flights on Thursdays between Copenhagen and Bergamo, northeast of Milan, have also been cancelled in the same period.
  • Tesla partners with AMD/GloFo for self driving vehicle  AI processor

    Tesla partners with AMD/GloFo for self driving vehicle AI processor

    Heading Tesla's silicon project is Jim Keller, a veteran chip architect who has previously worked at both Apple and AMD . Tesla CEO Elon Musk has said it has been a "tough slog" transitioning from the reliance on Mobileye's vision chips.
    Ryanair CEO vows damaging cancellation

    Ryanair CEO vows damaging cancellation "mess" will not happen again

    Be sure to document what you spend, though and keep receipts. "This is when having a decent policy can really come in handy". Initially, Ryanair was only making available lists of cancelled flights up to this Wednesday, 20 September .
    White House confirms Trump's plans to withdraw from Paris climate deal

    White House confirms Trump's plans to withdraw from Paris climate deal

    The U.S. has the world's second highest level of greenhouse-gas emissions, which drive global warming, behind China . Under the agreement's terms, Trump's decision to withdraw can not fully take effect for nearly four years.
  • Suspect dies in Huntington Beach officer-involved shooting captured on video

    Suspect dies in Huntington Beach officer-involved shooting captured on video

    Police say a man is dead after he was shot by a police officer outside of a 7-Eleven in Huntington Beach, Calif. The lockdown was lifted at about 11:15 a.m. "That was actually basically seeing a person die".
    Snap removes Al Jazeera channel in Saudi Arabia

    Snap removes Al Jazeera channel in Saudi Arabia

    The cease in relations came after Qatar was accused of supporting radical Islamist groups earlier this summer. Saudi Arabia, with its bulging youth population, is among the world's top users of social media per capita.
    National Cheeseburger Day 2017: Free Burger Deals at McDonald's, Shake Shack, More

    National Cheeseburger Day 2017: Free Burger Deals at McDonald's, Shake Shack, More

    The post National Cheeseburger Day 2017: Free Burger Deals at McDonald's, Shake Shack, More appeared first on InvestorPlace . Today, you can get that freebie from McDonald's , as they celebrate National Cheeseburger Day by giving cheeseburgers.
  • Apple releases macOS High Sierra update

    Apple releases macOS High Sierra update

    They'll slash the amount of space that photos and videos take up on your system, while retaining the same image and video quality. Are any of you now using a Mac? The problem (as you've likely guessed) is that this data is anything but secured.
    Packers come back in 27-24 overtime win over Bengals

    Packers come back in 27-24 overtime win over Bengals

    But that had more to do with him playing on such a polarizing team. "No surprise on Geronimo", Packers coach Mike McCarthy said. However, Aaron Rodgers led the team to overtime thanks to his 313 yards passing and three touchdowns.
    Countries begin signing nuclear ban treaty at UN

    Countries begin signing nuclear ban treaty at UN

    It will keep us on track for achieving our goal of a world in which nuclear weapons exist only in movies or books. Scores of police were soon on the scene but did not appear to be intent on brining the protest to a quick end.


Most liked

Hot Stocks Report: CVS Health Corporation (CVS), Suncor Energy Inc. (SU)
Currently, 397.5 million total shares are owned by the public and among those 394.5 million shares have been available to trade. Arete Wealth Advisors Llc decreased Barrick Gold Corp (NYSE:ABX) stake by 26,994 shares to 100,914 valued at $1.61M in 2017Q2.

Ryan Tubridy interviews Hillary Clinton for The Late Late Show
She was taking a swipe at a large swath of the population - according to exit polls , 41 percent of women voted for Trump in November.

Ryanair cancels MORE flights, affecting 400000 extra bookings until March
Ryanair has announced that it is cancelling its flights from Edinburgh and Glasgow to London Stansted over the winter. Ryanair has said it will slow the company's growth plan for the winter to help alleviate roster issues.

Jared Kushner Used Private Email Account For Official White House Business
Indeed, during his election campaign, Trump threatened to jail Clinton over her use of private email if he won the election. The FBI investigated her use of the server and found that nothing was found to warrant criminal charges against her .

Mexico volcano 'erupts' AGAIN after deadly quake
While survival for those trapped becomes a faint reality after several days without food or water, it is not an impossibility. There were also 73 deaths in Morelos state, 45 in Puebla, 13 in the State of Mexico , six in Guerrero and one in Oaxaca.

Saints take early lead, Panthers finally allow a touchdown
Brees has thrown for 1,252 yards and 12 touchdowns with three interceptions in his last four games against the Panthers . He has 6,743 career rushing yards and needs 104 to become the team's all-time leader ( DeAngelo Williams gained 6,846).

Jaguars Owner Says He Was Proud to Join Players
Even New England Patriots owners Bob Kraft, a longtime Trump supporter, has now lined up against the president on this one. NFL players knelt for the national anthem in droves after days of criticism from President Donald Trump on Sunday.

Merkel makes final push as election looms
The AfD approach is abhorrent and often nonsensical, says Gero Neugebauer, a retired professor and political analyst in Berlin . In many ways, it has been the exact opposite, even though the far-right is expected to make significant gains on Sunday.

Turkish government seeks mandate for troops in Syria and Iraq
It called for "dialogue and compromise" between the Kurdistan government and the central government in Baghdad. The three northern states that are predominantly Kurdish are governed by a separate president and parliament.

What you need to know about the Invictus Games
William and Kate travelled to the Danish capital to support Unicef's East Africa appeal and toured the organisation's emergency supply centre.

Two London Tube Attack Suspects Were Foster Children, Officials Say
The men, understood to be from Iraq and Syria respectively, are believed to have both been fostered by the same British couple. THIS is the moment a man arrested over the Parsons Green bombing shouted "I'm sorry" as he was pinned to a wall by police.

Brighton must learn to rebound from disappointment, says Hughton
The 29-year-old agreed to sign for Brighton on a season-long loan from Newcastle United in August, but that deal has now been made permanent.

OECD upgrades eurozone and China growth forecasts; United Kingdom and U.S. unchanged
Canada is set to log the fastest growth among advanced economies this year with the country's projection raised to 3.2% from 3%. India's growth estimate was cut to 6.7% from 7.3% previously, due to the impact of reforms on goods and services tax.

Sizzling Stock Touches New Recent High: Pfizer Inc. (NYSE:PFE)
Mckinley Capital Management LLC Delaware purchased a new stake in shares of Pfizer during the second quarter worth $103,000. Heading into the stock price potential, Pfizer Inc. needs to grow just 4.37% to cross its median price target of $37.

David Luiz 'broke wrist' against Arsenal
Chelsea kicked off their Champions League campaign with a thumping 6-0 win over Qarabag last week at Stamford Bridge. Andreas Christensen is expected to replace Luiz in Conte's starting XI until the Brazil global is available again.