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Medical device clinical trials vary widely in cost depending on device risk class, study design, patient count, duration, and endpoints . Typical total budgets range from ≈$1 M to $20 M+  for studies supporting regulatory submissions – with higher budgets common for large pivotal trials. Per-participant costs for device studies often range from about $14,000 to $50,000+ per enrolled patient  depending on complexity and follow-up. Many companies overspend because they assume c

Choose your sterilization method based on material compatibility first , then regulatory precedent, cost, and timeline . Ethylene oxide (EO) is the most widely used method across medical devices and works for many complex, low-temperature materials, but total turnaround often takes 1–3 weeks  including aeration. Steam sterilization is the fastest and least expensive , but only suitable for heat- and moisture-stable devices. Gamma radiation is effective for some polymers but c

For most Class II medical devices cleared through the 510(k) pathway , companies should plan for multiple years from concept to commercial launch , not months. While every product is different, 18–36 months  is a common planning range once design complexity, testing, and regulatory realities are accounted for. FDA does not publish end-to-end “time-to-market” timelines. Delays usually come from underestimating development effort, testing lead times, and regulatory iteration ,

FDA expects performance testing that demonstrates your device functions as intended and does not raise different questions of safety or effectiveness compared to your predicate. The scope of testing depends on device type, risk, and technological differences, but most 510(k)s include bench or performance testing , software validation where applicable , and biocompatibility assessment for patient-contacting components . This guide shows you exactly which tests FDA requires for

If FDA disagrees with your predicate choice, you'll get an Additional Information (AI) request or a Not Substantially Equivalent (NSE) determination. AI requests often add months and require either: (1) switching to a different predicate, (2) providing stronger substantial equivalence rationale, or (3) withdrawing and refiling. Not Substantially Equivalent (NSE) determination usually means you must submit new 510(k) with different predicate or pursue De Novo. This guide walks

Human Factors Engineering (HFE), also called usability engineering, is how FDA expects you to show that intended users can operate your device safely and effectively in the intended use environment, especially when use error could cause harm. For many higher-risk device types, FDA often expects human factors data in 510(k)s and PMAs, and it is common to see it in De Novo programs when the user interface drives risk. If you change a user interface in a way that can affect comp

A 510(k) submission costs between $50,000 and $250,000+ depending on device complexity, testing requirements, and whether you use consultants. Core costs include FDA user fees ($6,517-$26,067), testing/validation ($20,000-$150,000+), consultant fees ($15,000-$50,000), and establishment registration ($11,423). Most startups underestimate by 40-60%, with hidden costs from AI requests, design changes, and regulatory delays adding $30,000-$100,000+ to initial budgets. You've bui

FDA 510(k) submissions most often stumble on preventable issues: incomplete or non-compliant admin packets at Refuse to Accept (RTA) review, weak or inconsistent device descriptions and indications for use, poor predicate selection, missing or insufficient testing data, and failure to follow device-specific FDA guidance. Historically, RTA refusal rates have climbed as high as ~60% of new 510(k)s, and even in recent years roughly one-third of submissions hit an RTA hold at lea

A medical device regulatory strategy is your comprehensive plan for achieving FDA clearance or approval. It includes device classification, pathway selection (510(k), De Novo, or PMA), resource planning (team, budget, consultants), timeline mapping, testing strategy, and risk mitigation. Build it during concept phase—before design freeze or testing begins—to avoid expensive mistakes and accelerate market entry. Companies that build regulatory strategy during concept phase mak