Medical Device Regulatory Solutions
From product classification to application submission, our team offers full turnkey regulatory solutions to bring your medical device to the US market quickly and efficiently.
Medical Device Regulatory Solutions
From product classification to application submission, our team offers full turnkey regulatory solutions to bring your medical device to the US market quickly and efficiently.
The regulatory submission pathway needed to bring your medical device to market is dependent on its regulatory classification , which is determined by multiple factors, such as risk level, intended product use, and the presence or absence of a medical device of substantial equivalence (SE) already on the market.
Not sure which pathway your product falls under? Contact us today to schedule a consultation. Our team will not only review your product details and advise on the best pathway to bring your product to market but can also manage your regulatory submission process start to finish.
Our expert regulatory team offers full turnkey solutions for a variety of US medical device submission types and registration services:
Facilities that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807). It is common for these facilities to also be required to submit a list of the devices being made or distributed and the activities involved with those devices to the FDA Unified Registration and Listing System (FURLS).
An Emergency Use Authorization (EUA) is a temporary marketing authorization granted by the Food and Drug Administration (FDA) for previously unapproved medical products, or unapproved uses of approved medical products, to be used to help prevent, diagnose, or treat diseases or conditions caused by a public health emergency, such as Covid-19. Companies that have been granted EUAs and intend to keep their products on the market following the end of the public health crisis will need to complete a 510(k) submission to remain compliant.
A 510(k) premarket notification is a required regulatory submission for most class I and class II medical devices to gain market authorization in the United States. The application is submitted to the US Food and Drug Administration (FDA) and must demonstrate that the medical device is as safe and effective, that is, substantially equivalent (SE), to a device that is currently being legally marketed in the United States.
A De Novo Classification Request, or 513(a)(1), is a formal request to the US Food and Drug Administration (FDA) to classify a novel medical device for which general controls provide reasonable assurance for the medical device’s safety and effectiveness in the device’s intended use, but for which there is no substantially equivalent (SE) medical device currently being legally marketed in the United States. A device that is classified as a class I or class II device through a De Novo classification request can then be marketed and used as a predicate device for future 510(k) submissions when applicable.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization to administer an investigational drug or biological product to humans. Such authorization must be secured from the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. An IND is necessary to begin the clinical studies needed for a company to submit a formal New Drug Application (NDA).
A New Drug Application (NDA) is the application in which drug sponsors formally propose that the FDA’s Center for Drug Evaluation and Research (CDER) approve a new pharmaceutical product for interstate sale and marketing in the United States. NDAs include all data gathered in the Investigational New Drug (IND) clinical trials.
The Biologics License Application (BLA) is a request for permission from the FDA’s Center for Biologics Evaluation and Research (CBER) to introduce, or deliver for introduction, a biologic product into interstate commerce in the United States. Examples of biologics products include vaccines, gene therapies, and allergenics.
Our expert regulatory team offers full turnkey solutions for a variety of US medical device submission types and registration services:
Facilities that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807). It is common for these facilities to also be required to submit a list of the devices being made or distributed and the activities involved with those devices to the FDA Unified Registration and Listing System (FURLS).
An Emergency Use Authorization (EUA) is a temporary marketing authorization granted by the Food and Drug Administration (FDA) for previously unapproved medical products, or unapproved uses of approved medical products, to be used to help prevent, diagnose, or treat diseases or conditions caused by a public health emergency, such as Covid-19. Companies that have been granted EUAs and intend to keep their products on the market following the end of the public health crisis will need to complete a 510(k) submission to remain compliant.
A 510(k) premarket notification is a required regulatory submission for most class I and class II medical devices to gain market authorization in the United States. The application is submitted to the US Food and Drug Administration (FDA) and must demonstrate that the medical device is as safe and effective, that is, substantially equivalent (SE), to a device that is currently being legally marketed in the United States.
A De Novo Classification Request, or 513(a)(1), is a formal request to the US Food and Drug Administration (FDA) to classify a novel medical device for which general controls provide reasonable assurance for the medical device’s safety and effectiveness in the device’s intended use, but for which there is no substantially equivalent (SE) medical device currently being legally marketed in the United States. A device that is classified as a class I or class II device through a De Novo classification request can then be marketed and used as a predicate device for future 510(k) submissions when applicable.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization to administer an investigational drug or biological product to humans. Such authorization must be secured from the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. An IND is necessary to begin the clinical studies needed for a company to submit a formal New Drug Application (NDA).
A New Drug Application (NDA) is the application in which drug sponsors formally propose that the FDA’s Center for Drug Evaluation and Research (CDER) approve a new pharmaceutical product for interstate sale and marketing in the United States. NDAs include all data gathered in the Investigational New Drug (IND) clinical trials.
The Biologics License Application (BLA) is a request for permission from the FDA’s Center for Biologics Evaluation and Research (CBER) to introduce, or deliver for introduction, a biologic product into interstate commerce in the United States. Examples of biologics products include vaccines, gene therapies, and allergenics.
