- 510(k): Premarket Notification. Requires a manufacturer who intends to market a medical device to submit a premarket notification [510(k)] to the Agency at least 90 days before introducing the device onto the market. Demonstrate that new device is substantially equivalent (SE) to predicate device.
- Abbreviated 510(k): Submission must rely on: FDA Guidance Document(s), Demonstration of compliance with special control(s) for the device type, or Voluntary consensus standard(s)
- Adverse event: An adverse event is any undesirable experience associated with the use of a medical product in a patient
- Breakthrough Devices Program: Voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
- CA: Competent Authority. Acts as Ministry of Health within each member state.
- CBER: Center for Biologics Evaluation and Research. Regulates biological products for human use.
- CDER: Center for Drug Evaluation and Research. Regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
- CDRH: Center for Devices and Radiological Health. Regulate medical devices and safe radiation-emitting products.
- CE Mark: Conformity mark that all medical devices must have prior to marketing in the EU. Declaration by the manufacturer that the device meets all the appropriate provisions of the legislation and, where required, has been assessed in accordance with these.
- CER: Clinical Evaluation Report. Documents the conclusions of a clinical evaluation of your medical device
- Classification: Based on perceived risk of the product type and intended use. Provide the applied rules and regulations for each class by health authorities
- Combination Product: A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic)
- Corrective action: Action taken to eliminate the cause of a potential or actual non-conformity or another undesirable situation
- De Novo Classification: Utilizes a risk-based strategy. Reserved for new, novel devices whose type has not been previously classified (i.e. no predicate)
- Design Dossier: Under MDD, documentation for Class III devices submitted to NB for review prior to CE marking
- Device deficiency: Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer
- DOC: Declaration of Conformity. Statement by which a manufacturer affirms that its device meets all essential requirements, has undergone the appropriate conformity assessment procedures and is designed, manufactured and tested in accordance with technical documentation.
- EC: European Commission. Responsible for proposing legislation, implementing decisions, upholding the Union’s treaties and the general day-to-day running of the Union.
- ER: Essential Requirements. Requirements for safety and performance, define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. Under MDR, General Safety and Performance Requirements (GSPR).
- EU: European Union. Single market of 27 member countries, allows for ability of harmonization in legislation and the freedom of movement of: Goods, Services, People, Money.
- EU Decision: Binding on those to whom it is addressed (e.g. an EU country
- EU Directive: Legislative act that sets out a goal that all EU countries must
- EU Guideline: Intended to fulfill a legal obligation or provide advice on the most appropriate way to fulfill a legal obligation
- EU Regulation: Binding legislative act
- EUMDR: Medical Device Regulation. *See EU Regulation definition
- FDA: Food and Drug Administration. An agency of Department of Health and Human Services (DHHS), with a mission to protect and promote the public health. Oversee food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
- Field safety corrective action: Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market
- Field safety notice: Communication sent by a manufacturer to users or customers in relation to a field safety corrective action
- Gap Analysis: Assess clients documentation and provide recommendations to ensure compliance with current regulations
- GMDN: Global Medical Device Nomenclature. Generic names used to identify all medical device products. Provides a naming system used in exchanging medical device information and to support patient safety.
- GSPR: General Safety and Performance Requirements (GSPR). *See ER definition
- HDE: Humanitarian Device Exemption. A marketing application for an HUD, exempt from effectiveness requirements and subject to certain profit and use restrictions. *See HUD definition
- HUD: Humanitarian Use Device. A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
- IDE: Investigational Device Exemption. A regulatory submission that permits clinical investigation of devices in the United States.
- Incident: Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect
- IVDR: In Vitro Diagnostic Regulation. *See EU Regulation definition
- Least Burdensome: The minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time
- Market surveillance: Activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonization legislation and do not endanger health, safety or any other aspect of public interest protection
- MDSAP: Medical Device Single Audit Program. A global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. Members = Australia, Japan, Brazil, USA, Canada
- Medical Device: Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Does not achieve its primary intended purposes through chemical action (pharmacological).
- MDD: Medical Device Directive. *See EU Directive definition
- Notified Body: An organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.
- PER: Performance Evaluation Report. CER for IVD product. *See CER definition
- PMA: Premarket approval. The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
- PMOA: Primary mode of action. The single mode of action of a combination product that provides the most important therapeutic action of the combination product.
- Post-Market Surveillance: All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions
- Predicate Device: Legally marketed device that is not subject to PMA and used as a point of comparison for new medical devices
- QMS: Quality Management System. The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
- Quality: The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.
- Quality Assurance: Part of quality management focused on providing confidence that quality requirements will be fulfilled
- Quality Policy: The overall intensions and direction of an organization with respect to quality, as established by the management with executive responsibility.
- Quality Systems (QS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
- Recall: Any measure aimed at achieving the return of a device that has already been made available to the end user
- Regulatory (Affairs): Oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards
- Regulatory Strategy: Aligns the regulatory activities, together with the business strategy, to bring a new or modified medical device product to market. *Also see TPLC
- Remediation: Process of recognizing problems or gaps, making recommendations to correct them and ensuring they do not happen in the future. *Also see Gap Analysis
- SE: Substantial Equivalence. The device has the same intended use as the predicate device. The either has the same technological characteristics as the predicate device, or has different technological characteristics and demonstrates that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness than the predicate device.
- Serious adverse event: Any adverse event that led to any of the following:
(b) serious deterioration in the health of the subject, that resulted in any of the following:
(i) life-threatening illness or injury
(ii) permanent impairment of a body structure or a body function
(iii) hospitalization or prolongation of patient hospitalization
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
(v) chronic disease
(c) fetal distress, fetal death or a congenital physical or mental impairment or birth defect
- Serious incident : Means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person
(b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health
(c) a serious public health threat
- Serious public health threat : An event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time
- Special 510(k): Changes to own, existing device. Method(s) to evaluate the change(s) are well-established and results can be sufficiently reviewed in a summary or risk analysis format.
- Standard: A document, established by consensus that provides rules, guidelines, or characteristics for activities or their results.
- State of the Art Justification: Establishes the landscape and ground to support the relevance of the device as a treatment option for the condition treated
- Technical File : Under MDD, documentation for Class I, IIa, IIb devices retained by manufacturer for review by CA or NB, if required
- TPLC: Total Product Lifecycle. A conceptual framework for assessing any product or service. Will help guide the regulation of market-driven evolution of medical devices and radiation-emitting products from conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.
- US Guidance: Issued By FDA. Recommendations (Not Binding)
- US Laws: Enacted By Congress/President. Legally binding On FDA And Industry. (ex. Food, Drug, and Cosmetic Act – FD&C Act)
- US Regulations: Issued By FDA, Subject To Notice And Comment. Legally binding. (ex. Title 21 Of Code Of Federal Regulations (CFR))
Need Help? Contact Network Partners to help you plan for success.