| 3P 510(k) | Third-Party Review of 510(k) | Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types. |
| 510(k) | 510(k) Premarket Notification | FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. |
| 513(g) | 513(g) Request for Information | Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. |
| ACNU | Additional Condition for Nonprescription Use | FDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider. |
| ANVISA | ANVISA | Brazil's National Health Surveillance Agency, regulating medical devices and IVDs. |
| ASCA | Accreditation Scheme for Conformity Assessment | FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. |
| BDD | Breakthrough Device Designation | FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. |
| CDxmore than one meaning | Companion Diagnostic (IVDR) | IVD that is essential for the safe and effective use of a corresponding medicinal product to identify eligible patients or monitor treatment response. |
| CECP | Clinical Evaluation Consultation Procedure | MDR Article 54 procedure in which an independent expert panel reviews the notified body's clinical evaluation assessment for certain Class III and implantable Class IIb devices. |
| CSmore than one meaning | Common Specifications | Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient. |
| CSmore than one meaning | Common Specifications (IVDR) | Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used. |
| De Novo | De Novo Classification Request | Pathway to classify novel low- to moderate-risk devices that lack a predicate. |
| EC REP | Authorized Representative (EU) | Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. |
| eIFU | Electronic Instructions for Use | Provision of IFU in electronic form instead of, or in addition to, paper. |
| EUA | Emergency Use Authorization | FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies. |
| EURL | EU Reference Laboratory (EURL) | Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice. |
| FRIA | Fundamental Rights Impact Assessment | Assessment deployers of certain high-risk AI systems must complete before first use. |
| GPAI | General-Purpose AI Model | AI model trained on broad data at scale that displays significant generality and can be integrated into many downstream systems. |
| GSPR | General Safety and Performance Requirements (IVDR) | Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class. |
| GSPRs | General Safety and Performance Requirements | Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. |
| HDE | Humanitarian Device Exemption | FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year. |
| IFU | Instructions for Use | Information supplied by the manufacturer to inform the user of safe use of a device. |
| IFU (statement) | Indications for Use | Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. |
| IVDR | EU In Vitro Diagnostic Regulation | Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. |
| LTF | Letter to File | Internal documentation justifying that a device change does not require a new 510(k) submission. |
| MAF | Device Master File | Confidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them. |
| MDCG | Medical Device Coordination Group Guidance | Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements. |
| MDL | Health Canada Medical Device Licence | Authorization required to import or sell Class II, III, or IV medical devices in Canada. |
| MDRmore than one meaning | EU Medical Device Regulation | Regulation (EU) 2017/745 governing medical devices in the European Union. |
| MDUFA | Medical Device User Fee Amendments | Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years. |
| MFDS | Ministry of Food and Drug Safety (Korea) | South Korea's regulator for foods, drugs, cosmetics, and medical devices. |
| MHRA / UKCA | MHRA / UKCA Marking | UK regulator and post-Brexit conformity marking for medical devices in Great Britain. |
| NB | Notified Body | EU-designated organization that assesses conformity of medical devices under MDR and IVDR. |
| NMPA | National Medical Products Administration | China's regulatory authority for drugs, medical devices, and cosmetics. |
| PMA | Premarket Approval | FDA's most stringent device marketing application, required for high-risk Class III devices. |
| PMDA | Pharmaceuticals and Medical Devices Agency | Japan's regulatory authority for medical devices, drugs, and regenerative medicine. |
| PMPFmore than one meaning | Post-Market Performance Follow-Up (IVDR) | Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF. |
| PRRC | Person Responsible for Regulatory Compliance | Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer. |
| Q-Sub / Pre-Sub | Q-Submission (Pre-Submission) | Voluntary mechanism to obtain FDA feedback before a formal premarket submission. |
| RFD | Request for Designation | Formal mechanism to obtain a binding FDA decision on which Center will regulate a product. |
| RTA | Refuse to Accept | FDA administrative decision that a submission is incomplete and won't be substantively reviewed. |
| SE | Substantial Equivalence | The legal standard a 510(k) device must meet versus a predicate. |
| SFDA | Saudi Food and Drug Authority | Saudi Arabian medical device regulator; central authority for the GCC reliance pathway. |
| Special 510(k) | Special 510(k) | Streamlined 510(k) for modifications to a manufacturer's own legally marketed device. |
| SSCP | Summary of Safety and Clinical Performance | Public-facing summary required for high-risk and implantable devices under EU MDR. |
| SSP | Summary of Safety and Performance (IVDR) | Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED. |
| STeP | Safer Technologies Program | FDA program for devices addressing less serious conditions but offering meaningful safety improvements. |
| TGA | Therapeutic Goods Administration | Australia's regulator for therapeutic goods including medical devices and IVDs. |
| UDI | Unique Device Identification | System for adequate identification of medical devices through distribution and use. |
| UKRP | UK Responsible Person | UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market. |
| WHO PQ Dx | WHO Prequalification (Diagnostics) | WHO assessment of IVDs to support procurement by UN agencies and low- and middle-income countries. |