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FDA Additional Information (AI) requests flag deficiencies in a 510(k) during substantive review and place the submission on hold. The submitter has 180 calendar days from the date of the AI Request to provide a complete response, and FDA states no extensions beyond 180 days are granted. The most common AI Request themes typically include substantial equivalence gaps, missing or unclear test evidence, incomplete device description, software documentation issues, biocompatib

AI tools can speed up specific parts of FDA medical device regulatory work, especially first-pass predicate research, guidance discovery, requirements checklists, gap spotting, and first-draft writing. The biggest risk is accuracy: general-purpose LLMs can generate confident text with false facts or hallucinated citations, so you should treat them as drafting and research assistants, not as sources of truth. Specialized regulatory platforms like Complizen reduce verification

Biocompatibility testing evaluates whether a patient-contacting medical device could cause adverse biological responses. ISO 10993-1 provides a risk-management framework: categorize the device by nature of body contact (surface, external communicating, implant) and contact duration (limited ≤24 hours, prolonged >24 hours to 30 days, long-term >30 days), then justify the relevant biological endpoints based on the FDA/ISO tables and your risk assessment. Cytotoxicity, sensitiza

A medical device recall is a firm's removal or correction of a marketed device that violates FDA law or poses a health risk. FDA classifies recalls by severity: Class I (reasonable probability of serious adverse health consequences or death), Class II (temporary or medically reversible adverse health consequences), Class III (unlikely to cause adverse health consequences). Recalls are governed by 21 CFR Part 7, while corrections and removals reporting falls under 21 CFR Part

How Tariffs and Geopolitics Are Changing U.S. Market Entry for International Medical Device Manufacturers For years, regulatory strategy meant understanding the FDA. Guidance. Pathways. Testing requirements. That is no longer enough. Because increasingly, market access is being shaped by geopolitics, not just regulation. The Shift Regulatory and global strategy used to be separate. Now they are converging. The U.S. medical device market alone accounts for ~40% of global dema

International medical device manufacturers often run into the same avoidable U.S. market-entry mistakes: assuming CE-mark experience will translate cleanly to FDA, choosing the wrong predicate strategy, trying to reuse EU clinical data without reframing it for substantial equivalence, misunderstanding when a U.S. Agent is needed, missing U.S.-specific testing expectations, underestimating the burden of Additional Information requests, overlooking remaining QMSR gaps after ISO