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Premarket

Safety, effectiveness, and quality are the watchwords of the medical device industry, and companies commit time and expertise to ensure that their devices perform properly and serve patient needs. This commitment starts at the earliest design phase and continues through the development, manufacturing, and distribution of a device.

FDA uses a risk‑based premarket review system that determines the level of review based on the device type.  There are two main pathways to market:

  • Low-to moderate-risk device types that have a well-established safety profile are cleared through the premarket notification or 510(k) process.
  • Higher-risk technologies that often involve novel or first-of-a-kind innovations follow the premarket approval (PMA) application process.

Regardless of the pathway, FDA determines the evidence necessary before any new device or diagnostic can be deemed safe and effective, and the data that companies need to provide is comprehensive and thorough.

510(K)

FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices.

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Premarket Approval (PMA)

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.  Class III devices support or sustain human life, are critically important to prevent impairment of human health, or present a potential, unreasonable risk of illness or injury.  PMA is the most stringent type of device marketing application that FDA requires. When PMAs involve novel technologies or uncertainty about whether a device’s benefits outweigh its risks, FDA may seek advisory committee input.

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Medical Device User Fee Agreement (MDUFA)

Under the “Medical Device User Fee and Modernization Act of 2002” (MDUFMA), FDA was given the authority to collect user fees from medical device sponsors for review activities. Under the legislation, FDA committed to meeting specific performance goals negotiated between industry and the agency related to medical device reviews.

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Clinical Trials

FDA may require device sponsors to conduct a clinical trial to establish the safety and efficacy of the medical device.  When a trial is required, device sponsors must comply with numerous regulations and FDA guidance to: obtain FDA approval to ensure the trial design is safe and protects human subjects; ensure informed consent of human subjects; obtain approval from an Institutional Review Board (IRB); to properly collect and monitor data from the trial; and to report and evaluate age, race, ethnicity and gender data; among other items.