Even experienced teams can stumble in FDA strategy. From misclassifying devices to neglecting FDA communication, these pitfalls delay clearance and risk compliance. Learn the most frequent mistakes in regulatory planning—and how to avoid them for smoother approvals.
Even the best-intentioned teams can stumble in their FDA strategy. Here are some frequent strategic mistakes device companies make in planning their regulatory pathway – and tips on how to avoid them:
A classic error is assuming a device is Class I or II (510(k)-eligible) when it’s actually higher risk or novel, thus requiring De Novo or PMA. This misstep can stem from superficial research or wishful thinking. The result? Months wasted preparing a 510(k) that FDA refuses to accept or deems Not Substantially Equivalent, forcing a restart on the correct path.
How to avoid: Do your classification homework thoroughly. Search FDA’s databases and predicate listings. If in doubt, use a 513(g) query or Pre-Submission to ask FDA about your device’s classification. It’s better to pursue the proper pathway from the start than to course-correct under pressure.
Many companies assume that minimal testing will suffice, only to have FDA ask for more data. For example, submitting a 510(k) without required biocompatibility reports or with too small a clinical sample. FDA’s Refuse to Accept (RTA) check will reject 510(k)s that lack key pieces. And even if you pass RTA, insufficient evidence will bring numerous deficiencies later.
How to avoid: Build a robust evidence plan from the outset. Follow FDA guidance on required testing. Use consensus standards and ensure test reports are complete. Think like a reviewer – if omitting a test would raise a safety/effectiveness question, include it. If unsure, ask FDA in a Pre-Sub whether your planned test matrix is adequate.
Some teams avoid contacting FDA before submission, fearing unwanted feedback or delays. This “fly under the radar” approach often backfires. By not engaging (e.g. skipping a Pre-Sub), companies miss the chance to clarify uncertainties. The mistake surfaces later as unexpected questions or even a rejection that could have been resolved earlier.
How to avoid: Embrace dialogue with FDA. Use Pre-Subs to test the waters on your strategy, ask about novel aspects, or confirm testing protocols. It’s far better to incorporate FDA’s input during development than to discover a fatal issue during review. A collaborative tone with the Agency can smooth the entire process.
Regulatory strategy doesn’t end with the submission – FDA will scrutinize your underlying quality practices too. A common oversight is failing to have proper design control or risk management documentation, or not having a compliant Quality System in place. These can lead to inspection findings or even submission holds (FDA may delay clearance if a facility has serious compliance issues).
How to avoid: Align your regulatory plan with quality requirements. Ensure your Design History File, risk management file, and test reports are well-organized and ready for review. Before submission, do an internal audit to catch documentation gaps. Remember, regulatory strategy and quality compliance go hand-in-hand – a weakness in one can derail the other.
Some treat FDA approval as the finish line and fail to plan for postmarket obligations. This can be a strategic blunder. Examples include not preparing for required post-approval studies for a high-risk device, or being unaware of reporting duties (MDRs, recalls). If a product change is needed later, some firms implement it without assessing if a new 510(k) is required, leading to compliance issues.
How to avoid: Incorporate lifecycle thinking. If FDA approval comes with conditions (like a postmarket study), have a plan and budget to fulfill them. Educate your team on what postmarket changes trigger a new submission (FDA’s guidance on when to submit a new 510(k) is essential). By planning beyond the approval, you avoid scrambling later or, worse, falling out of compliance.
Each of these mistakes is preventable with foresight and the right approach. Successful regulatory strategy is as much about knowing what not to do as doing the right things. By learning from common pitfalls – and taking proactive steps to avoid them – you can smooth your device’s road to market. The cost of a misstep isn’t just a delayed clearance; it could mean lost investor confidence or market opportunity. ADBC CRO has guided many clients around these pitfalls, ensuring their regulatory path planning is solid, evidence-based, and communication-rich. With preparation and awareness, you can turn potential “learning experiences” into non-events – and get your device to patients without unnecessary detours.
