Medical devices regulation - USA

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices. Prior to entry into the US marketplace, many devices require premarket submissions so FDA can evaluate the safety and efficacy characteristics of the device in question. There are several different types of premarket submissions. For many devices, the applicable type of premarket submission is known as a premarket notification, commonly referred to as a 510(k).

The pace of technological innovation means that medical device manufacturers face significant challenges in identifying the correct regulatory pathway for their products. TSG’s scientific and regulatory specialists have extensive experience in the public and private sectors, assisting medical device companies in getting their products to market. Our experts can help identify the appropriate (or desirable) premarket submission type for a given device, as well as develop a corresponding device-specific submission strategy. We can also help determine when such submissions are not required for commonly marketed and low-risk medical devices.

TSG can help:

  • Determine the appropriate regulatory pathway for a device, including cases where premarket submissions are not required
  • Assist in determining the product code, related regulations, 513(g) submission, pre-submission meetings, and premarket notification i.e. 510(k) and de novo
  • Develop a strategy to establish substantial equivalence (SE) for medical devices that require 510(k) submission
  • Identify de novo submission pathway for reclassification of novel devices
  • Represent clients in pre-submission meetings for device-specific claims
  • Advise on and review safety and effectiveness data including material composition, biocompatibility, sterilization (for single use devices), reprocessing (for multiuse devices) and performance testing
  • Assist in developing device labels for both single use and multiuse devices
  • Coordinate fee payment and submitting required documentation for 510(k) submissions
  • Obtain regulatory clarity for those FDA-regulated medical devices which the Environmental Protection Agency (EPA) may view as being wholly or partially within its regulatory authority
  • Act as a liaison with regulatory authorities
  • Guide clients through establishment registration and listing requirements

Need help with a 510(k) submission?

Why TSG

TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance 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 measure to cultivate long-term partnerships with clients.

Our professionals

Our medical device compliance consulting team includes Dr Om Singh, who is a Senior Scientific Consultant at TSG Consulting. He has substantial experience working with companies looking to commercialize medical devices and antimicrobial products such as sterilants, high-level disinfectants, and antiseptics. His previous experience working at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) allows him to better advise companies of anticipated regulatory hurdles when seeking approval and registration for their human health products.

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It depends upon the nature of the product you intend to market in the U.S. – its risk profile and how uncommon it is. TSG can help you to determine the regulatory path forward for FDA clearance of your product.

It would depend on the device type. However, FDA has set a goal to review and respond to 510(k) applications within 90 calendar days. Clearance of the device will depend on the time you take to respond to any additional information (AI) requests from FDA after the review.

The standard Federal fees from the FDA vary for different submission types. There will be consulting fees to pay additionally which will depend upon the complexity of the product being marketed.

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