FDA Medical device regulation – USA

Achieving 510(k) clearance from the US Food and Drug Administration (FDA or the Agency) is widely regarded as one of the most challenging aspects of medical device development. TSG’s Medical Device Regulatory Consulting team has the experience to guide you through all stages of the FDA’s regulation of medical devices.

Need help with a Pre-Submission or 510(k) premarket notification?

Why TSG

TSG provides companies with high-quality regulatory and scientific consulting services. Uniquely positioned to offer both medical device development (through our sister company Sagentia Innovation) and in-house FDA regulatory expertise, TSG helps clients deliver FDA-compliant, innovative medical devices across the patient care continuum. We aim to understand our clients’ goals and objectives, learn the scientific and technical aspects of projects, and anticipate regulatory challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive, and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great care to cultivate long-term partnerships with clients.

Our professionals

Our medical device regulatory consulting team is led by Laurie Clarke, JD, MPP, AB. Her knowledge and experience as a former FDA partner at top-ranked law firms enables her to effectively advise and advocate for clients throughout a device’s lifecycle. Laurie specializes in helping medical device companies develop and implement regulatory strategies that meet their marketing objectives. She has extensive experience assisting clients with investigational device exemptions (IDE), 510(k) premarket notifications, premarket approval applications (PMA), de novo review submissions, pre-submissions, requests for designation of combination products as devices, and 513(g) requests for a wide range of devices. She is also experienced in preparing clients for, and representing them at, FDA meetings.

Useful information

The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device in Section 201(h) of the Food, Drug, and Cosmetic (FDC) Act. TSG can help you: (1) determine if your product or part of the finished product meets the definition of a medical device; or (2) analyze if your product meets the definition of a combination product that includes a device and at least one drug and/or biologic. If it is unclear whether your product is a device or a device-led combination product, we can help you prepare a 513(g) request to FDA’s Center for Devices and Radiological Health (CDRH) and/or a Request for Designation (or a pre-RFD) to FDA’s Office of Combination Products (OCP) to obtain a definitive answer. Further, TSG can support you in documenting in an internal memorandum-to-file that the product is not a device or FDA is exercising its enforcement discretion and not regulating it as a device if you decide to market it based on either of those grounds.

Yes, you will need the Agency’s authorization to market an FDA-regulated medical device in the US unless the device is exempt from 510(k) requirements. Determining whether a device requires FDA premarket review, and if so the type of premarket submission that applies to it, can be complex. TSG can research whether FDA has classified the type of device as Class I (lowest risk), II and/or III (highest risk) and the type of premarket submission it requires. Class III devices require approved PMAs. Most, but not all, Class II devices require 510(k) clearance. However, there are limitations on the 510(k) exemptions for Class I and Class II devices.

We can help you determine whether the 510(k) exemption for a type of device applies to your specific device. Please contact us at info@tsgconsulting.com to speak with our medical device regulatory consulting team about obtaining FDA authorization to market your device.

FDA regulations and guidance documents specify the basic content and format requirements for different types of submissions. We can help you determine the type and amount of information that FDA is likely to require in the premarket submission for your device. We can also help you prepare a pre-submission to obtain FDA’s preliminary feedback on whether the existing, ongoing, or proposed testing will produce the data the Agency needs to evaluate the safety and efficacy of the device. Further, we can review and comment on protocols for performance (bench, animal and clinical), biocompatibility, and human factors testing of your device to help ensure that the data meets FDA’s requirements. As FDA 510(k) consultants, we have extensive experience with 510(k)s, which are the most common type of premarket submission. 

The FDA has different requirements depending on the risk the study presents. TSG’s medical device regulatory team can work with you to determine whether a proposed clinical study is: a significant risk (SR) device study that requires FDA approval of an investigational devices exemption (IDE) application; a nonsignificant risk (NSR) that is deemed to have an approved IDE; or a study that is exempt from FDA’s IDE requirements. We can then help you comply with the applicable IDE requirements. We also can help you comply with FDA’s requirements regarding Institutional Review Board (IRB) approval, informed consent, and disclosure of clinical investigators’ financial interests in the product and/or the study sponsor.

If the device requires 510(k) clearance, we can help identify potential predicate and reference devices, determining the primary and any secondary predicates, comparing the new device to its predicate(s), assessing the test data, developing or evaluating the substantial equivalence argument, and drafting the 510(k) or reviewing and commenting on the company’s draft submission. In addition, we can review de novo requests, HDEs, and PMAs, as well as IDEs. Moreover, we can guide you through the processes for obtaining small business designation, if you qualify, and for paying FDA’s standard or small business user fee for the type of submission. We also can help you respond to any request for additional information from FDA during the Agency’s review of the submission, as well as represent your company at FDA meetings. To discuss your support needs further, please get in touch at info@tsgconsulting.com

Yes, you will need to comply with at least two additional FDA requirements to market your device after you obtain 510(k)-clearance, de novo-authorization, HDE-approval, or PMA-approval, or it is 510(k) exempt. You will need to register as a device establishment (and pay the initial (annual) registration fee) or update your registration. In addition, you will need to list the new device or update your listing for that type of device. If your device is PMA or HDE approved, you must also satisfy the premarket conditions specified in the approval letter, e.g. the submission of final labeling. We can help you perform these tasks.

Yes, FDA’s device regulations, which are in 21 C.FR Part 800, specify requirements that apply to some or all marketed device (postmarket requirements) regarding labeling (Part 801), corrections and removals (Part 803), medical device reporting (Part 806), recalls (Section 810), Quality Systems Regulations (Part 820), device tracking (Part 821), postmarket surveillance (Part 822), and unique device identifiers (Part 830). In addition, FDA’s regulations regarding 510(k) notices (Part 807, Subpart E) and PMAs/HDEs (Part 814) require prior authorization from FDA for modifications to cleared or approved devices that meet certain criteria. Some requirements apply only to a specific device, such as a postapproval study that was a condition of approval of the device. We can identify the postmarket requirements that apply to your device(s) and assist you in complying with them. To speak with our medical device regulatory team about our postmarket services, please contact us at info@tsgconsulting.com

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