FDA Clearance
Definition
The regulatory authorisation granted by the US Food and Drug Administration permitting a medical device to be marketed in the United States, typically through the 510(k) premarket notification pathway for devices that are substantially equivalent to an existing legally marketed device. FDA clearance is distinct from FDA approval (required for higher-risk Class III devices via the Premarket Approval pathway) and represents a significant regulatory intangible asset. The 510(k) pathway is faster and less costly but requires demonstration of substantial equivalence to a predicate device.
Complementary Terms
Concepts that frequently appear alongside FDA Clearance in practice.
The regulatory process by which a pharmaceutical product receives authorisation for commercial sale, granted by agencies such as the FDA (US), EMA (EU), and MHRA (UK). Drug approval requires demonstration of safety, efficacy, and manufacturing quality through preclinical studies and clinical trials.
The authorisation granted by a government or regulatory body permitting a company to manufacture, market, or sell a product or service in a specific jurisdiction. Regulatory approvals — including drug approvals (FDA, EMA), financial service licences (FCA, MAS), telecommunications licences, and environmental permits — are recognised as contract-based intangible assets in purchase price allocations under IFRS 3 and ASC 805 when they arise from contractual or legal rights.
The regulatory categorisation system that assigns medical devices to classes based on their risk to patients, which determines the level of regulatory scrutiny required for market approval. The EU MDR uses four classes (I, IIa, IIb, III) while the FDA uses three (I, II, III).
The sequential stages of human testing required before a new drug or medical device can receive regulatory approval. Phase I assesses safety in a small group, Phase II evaluates efficacy and dosing, Phase III confirms effectiveness in large populations, and Phase IV involves post-market surveillance.
The EU regulatory framework (Regulation 2017/745) governing the design, manufacture, and distribution of medical devices in the European market, which replaced the Medical Devices Directive (93/42/EEC) with significantly stricter requirements. MDR imposes enhanced clinical evidence requirements, more rigorous conformity assessment procedures, a Unique Device Identification system, and comprehensive post-market surveillance obligations.
A mandatory conformity marking for products sold within the European Economic Area, indicating that the product meets EU health, safety, and environmental protection requirements. For medical devices, CE marking under the Medical Device Regulation (MDR 2017/745) requires conformity assessment by a Notified Body, clinical evaluation, and ongoing post-market surveillance.
A pharmaceutical product that contains the same active ingredient, dosage form, strength, and route of administration as an originator (branded) drug and is demonstrated to be bioequivalent. Generic drugs can be manufactured and marketed after the expiry of the originator's patent protection and regulatory exclusivity periods.
A regulatory authorisation permitting a firm to issue electronic money — digitally stored monetary value representing a claim on the issuer. In the UK, e-money licences are granted by the FCA under the Electronic Money Regulations 2011.
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