U.S. 510(k) Premarket Notification
A 510(k), formally known as a Premarket Notification, is a technical dossier submission that is required by the Food and Drug Administration (FDA) for qualifying medium-risk medical devices and in vitro diagnostic devices (IVD) to be legally marketed and distributed in the United States. These submissions must demonstrate the device meets product-specific safety and efficacy standards set by US regulatory agencies and prove the device is substantially equivalent to a predicate device (a device that has already been cleared by the agency for commercialization in the US) to be granted market authorization. Accorto offers full turnkey solutions for 510(k) medical device submissions. Contact us today to discuss how our team can achieve and maintain US market authorization for your medical devices.
U.S. 510(k) Premarket Notification
A 510(k), formally known as a Premarket Notification, is a technical dossier submission that is required by the Food and Drug Administration (FDA) for qualifying medium-risk medical devices and in vitro diagnostic devices (IVD) to be legally marketed and distributed in the United States. These submissions must demonstrate the device meets product-specific safety and efficacy standards set by US regulatory agencies and prove the device is substantially equivalent to a predicate device (a device that has already been cleared by the agency for commercialization in the US) to be granted market authorization. Accorto offers full turnkey solutions for 510(k) medical device submissions. Contact us today to discuss how our team can achieve and maintain US market authorization for your medical devices.
510(k) Preparation and Submission Services
510(k) Post-Market Surveillance Management
COVID-19 EUA Transition Services
510(k) Preparation and Submission Services
At Accorto, we know gaining market authorization in the US for your medical device can be one of the largest roadblocks your company will face on your journey to achieving your long-term business goals. Preparing a 510(k) can be challenging, and mistakes can result in severe setbacks to both your project timeline and budget.
Our team of regulatory experts specialize in the management of medical device and IVD regulatory submissions, working collaboratively with each of our clients to develop bespoke submission strategies unique to their specific device, intended device use, and their long-term business goals. Whether you are looking for a full turnkey management solution or guidance on how to manage your own submission, our team can help you achieve market authorization for your medical devices quickly and efficiently.
510(k) Post-Market Surveillance Management
Post market surveillance is the practice of monitoring the safety and efficacy of a medical device after it has been released to the market in the US and is a requirement to maintain market authorization with the FDA. Manufacturers are required to collect and report any data gathered on adverse effects from the device post-market. Once an adverse effect has been reported, the manufacturer is also required to investigate each report and promptly inform the FDA the results of their investigation and if the incident was directly related to the device in question. Failure to properly monitor, investigate, or report post-market surveillance data may result in the termination of the device’s market authorization.
Accorto offers full turnkey post-market surveillance management solutions as a part of our suite of 510(k) service offerings. From initial surveillance plan development and implementation, to collection of incident reports and device usage feedback from customers and patients, to periodic report development and submission and annual reporting, Accorto can manage your full post-market surveillance process start to finish and every step in-between.
COVID-19 EUA Transition Services
FDA has begun revising their guidance and reducing the EUA scope for COVID-19 related devices. Companies currently marketing COVID-19 related medical devices under the EUA pathway will need to ensure they comply with all regulatory requirements for 510(k) premarket notification submissions if they intend on continuing commercialization following the conclusion of their EUA. At Accorto, we will develop a post-EUA submission strategy to achieve and maintain long-term market authorization for your in vitro diagnostic devices, personal protective equipment, and respiratory assistance devices, far beyond the COVID-19 pandemic.
510(k) Preparation and Submission Services
At Accorto, we know gaining market authorization in the US for your medical device can be one of the largest roadblocks your company will face on your journey to achieving your long-term business goals. Preparing a 510(k) can be challenging, and mistakes can result in severe setbacks to both your project timeline and budget.
Our team of regulatory experts specialize in the management of medical device and IVD regulatory submissions, working collaboratively with each of our clients to develop bespoke submission strategies unique to their specific device, intended device use, and their long-term business goals. Whether you are looking for a full turnkey management solution or guidance on how to manage your own submission, our team can help you achieve market authorization for your medical devices quickly and efficiently.
510(k) Post-Market Surveillance Management
Post market surveillance is the practice of monitoring the safety and efficacy of a medical device after it has been released to the market in the US and is a requirement to maintain market authorization with the FDA. Manufacturers are required to collect and report any data gathered on adverse effects from the device post-market. Once an adverse effect has been reported, the manufacturer is also required to investigate each report and promptly inform the FDA the results of their investigation and if the incident was directly related to the device in question. Failure to properly monitor, investigate, or report post-market surveillance data may result in the termination of the device’s market authorization.
Accorto offers full turnkey post-market surveillance management solutions as a part of our suite of 510(k) service offerings. From initial surveillance plan development and implementation, to collection of incident reports and device usage feedback from customers and patients, to periodic report development and submission and annual reporting, Accorto can manage your full post-market surveillance process start to finish and every step in-between.
COVID-19 EUA Transition Services
FDA has begun revising their guidance and reducing the EUA scope for COVID-19 related devices. Companies currently marketing COVID-19 related medical devices under the EUA pathway will need to ensure they comply with all regulatory requirements for 510(k) premarket notification submissions if they intend on continuing commercialization following the conclusion of their EUA. At Accorto, we will develop a post-EUA submission strategy to achieve and maintain long-term market authorization for your in vitro diagnostic devices, personal protective equipment, and respiratory assistance devices, far beyond the COVID-19 pandemic.
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