The FDA is responsible for regulating the production and monitoring the safety of high-quality medical devices. Before the device can be sold in the U.S., the manufacturer must obtain FDA approval by presenting evidence that the device is safe and effective for a particular use. What’s more, regulatory control increases with the device class and its associated risk, which adds further complexity to an increasingly complicated process.
At Sterling Medical Devices, our medical device regulatory compliance consultants take on that burden to help you meet the required regulatory controls that assure your medical device’s safety and effectiveness—throughout the entire product development life cycle. With a deep understanding of the many ins and outs of the FDA requirements processes, our medical regulatory consultants can help you with:
Medical device classification
Premarket clearance and approval
Marketing and reporting requirements
Inspections and enforcement
International and import/export issues
We’ll help you navigate the complex FDA premarket approval process, including:
Premarket Notification 510(k) Exemption: Most Class I and some Class II devices fall under a 510(k) exemption with the FDA. These devices may be sold in the U.S., provided the manufacturer registers and lists them with the FDA, and ensures it complies with the applicable requirements. Our medical regulatory consultants will guide you through the process to ensure your product meets the appropriate exemption criteria.
Premarket Notification 510(k): Manufacturers of low- to moderate-risk devices that do not qualify for an exemption but have a predicate device on the market can submit a 510(k) that proves the device is substantially equivalent to other devices previously cleared by the FDA. This can be a timely and complicated process—and that’s where we come in. More specifically, we will gather the appropriate information and documents required to support claims that your medical device is substantially equivalent to one or more legally marketed devices.
Premarket Approval (PMA) or De Novo: For Class III devices, those that support or sustain human life, a premarket approval (PMA) submission is required that proves the safety and effectiveness of their device. Manufacturers of low- to moderate-risk devices that do not have a substantially equivalent predicate device may request De Novo classification, whereby the device is down-classified to a Class I or II. To obtain market authorization under the De Novo pathway, the manufacturer must provide reasonable assurance of the device’s safety and effectiveness. We will manage the entire process to ensure you meet the necessary PMA or De Novo requirements.
513(g) Request for Information (Classification)
Ultimately, it is the responsibility of the manufacturer to determine device classification. But this is not always cut and dry. If you are unsure of the appropriate classification, you may submit a 513(g) Request for Information to the FDA. To do so, you must prepare a detailed device description, which includes indications for use, intended use, description of its fundamental operating technology, labeling, and comparison to a similar currently marketed device, if applicable. Leave those details to us; we’ll handle the process, start to finish.
Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.