The development stage is high-risk for FDA compliance. From design controls and documentation to device classification and regulatory pathway selection, early missteps can delay approval or trigger enforcement. Proactive risk checks help ensure audit-ready processes.
Figure: Example of frequency of different design control-related FDA Form 483 observations in FY2021 (e.g., RA = Risk Analysis, DI = Design Input, DV = Design Validation). Over one-third of all device Form 483s (64 out of 191 in FY2021) were related to design control deficiencies.
The product development stage is a high-risk period for regulatory compliance. Decisions and processes during R&D can either set a device up for smooth FDA approval or create compliance landmines down the road. One major area of risk is design controls, which are required by FDA’s Quality System Regulation for device development (21 CFR 820.30). In fact, FDA inspection data shows that design control deficiencies (such as missing or incomplete risk analysis, design inputs, or design validation) are among the most frequent issues cited in Form 483 inspection observations. Failing to meet these requirements during development can later result in approval delays or even product recalls. For example, not conducting a proper design validation (ensuring the device meets user needs and intended uses) or neglecting to include “risk analysis” in design validation are common pitfalls that have led to FDA findings. In one FDA warning letter, a manufacturer was cited for “failure to maintain a complete risk analysis, as required by 21 CFR 820.30(g),” because they had not updated their risk assessment when new product issues emerged. This illustrates how compliance and product development are intertwined – overlooking risk management in design can violate regulations.
Another critical regulatory risk in development is choosing the wrong regulatory pathway or misjudging device classification. Early in development, companies must identify whether their product is Class I, II, or III, and which submission (510(k), De Novo, PMA, etc.) applies. Misclassifying a device or underestimating requirements can be costly. For instance, a startup might assume their novel device only needs a 510(k) when in fact it requires a De Novo or PMA – leading to unexpected studies or rework. Engaging in a Pre-Submission with the FDA can mitigate this risk by clarifying the regulatory expectations before significant time and money are spent (more on Pre-Subs in a later section). Identifying regulatory risks means asking early on: “What could regulators fault in our development process or design?” Common issues to check include: incomplete design history files (DHF), missing design reviews, lack of software validation for software-based devices, or inadequate documentation of design inputs and outputs. Each of these is explicitly required by FDA regulations, so any gap is a potential non-compliance point.
Documentation is indeed a recurring theme. During development, teams must generate a slew of documents – requirements, schematics, test plans, verification and validation (V&V) results, etc. A regulatory risk arises if any of these documents are lacking or poorly done. FDA expects that design inputs (requirements) are established and reviewed, that design outputs are documented, and that design changes are controlled. Skipping steps to rush a prototype can backfire if you later cannot provide necessary evidence to FDA. For example, failing to document that you performed biocompatibility testing or electrical safety testing (when required) is a risk – it can result in a Refusal to Accept or additional information requests during submission, delaying approval. A real-world case noted in an FDA inspection: a company was cited for failing to conduct design verification testing to support the shelf life of device components. This kind of oversight not only violates 21 CFR 820.30 but also jeopardizes patient safety.
To identify such risks proactively, teams should conduct regulatory walkthroughs of the development process. This can involve using FDA’s own inspection criteria as a guide – for instance, the FDA’s Quality System Inspection Technique (QSIT) focuses on subsystems like Design Controls, Management Controls, CAPA, and Production processes. During development, ask: would our design history file pass an FDA audit? Are we maintaining a traceability matrix from user needs to design outputs and V&V tests? Have we assessed risk management according to ISO 14971 (which, while not legally required by FDA, is recognized as a consensus standard and helps in systematically identifying hazards and mitigations). FDA has increasingly emphasized the importance of risk management in design – manufacturers are expected to integrate risk considerations (probability and severity of harm) into their design decisions. Neglecting this could be deemed a regulatory risk.
Finally, consider regulatory risks related to innovation. In device development, novel technologies (like AI software, wearables, etc.) may lack clear precedents, which introduces uncertainty in what FDA will require. Identifying this as a risk means planning extra early consultations with FDA or experts, and not assuming the usual pathways apply. Startups should be especially cautious: medical device startups often face regulatory risks from inexperience, such as not implementing a quality management system during development or overlooking standards. In contrast, large manufacturers might have processes in place but face risk when deviating for a new project. In both cases, early identification of regulatory risks – through design reviews focused on compliance, internal audits, and expert input – is essential. By catching compliance issues in development, companies can avoid painful surprises later (like a clinical hold, a major redesign, or a submission rejection). In summary, the development phase should incorporate regulatory risk checkpoints at every stage to ensure the device and all documentation will withstand FDA scrutiny.
