Medical Device Terms
The list of terms and descriptions on this page are specific to the pharmaceutical industry. The information will be updated regularly with additional terms, expanded descriptions, and/or modifications to current descriptions. This information is for general information purposes only and is not intended to be and should not be taken as legal advice. There are multiple contributors to this page. Suggestions, comments and questions are welcome. Please email ccampillo@emerginghealthllc.com.
3P510k Review Program
See Third Party Review Organization.
510(k)
See Premarket Notification 510(k).
Abbreviated 510(k)
Premarket Notification 510(k) in which there is a reliance on the guidance documents, special controls, and recognized standards.
AIDC
Automatic Identification and Data Capture.
AI Request
Additional Information Request.
AP Program | APP
See Third Party Review Organization.
B-R Assessment
Benefit Risk Assessment
CDRH (pronounced “c-d-r-h”)
Center for Devices and Radiological Health is a branch of the FDA responsible for the premarket approval of medical devices and radiation-emitting products as well as their manufacturing, performance and safety.
CGMP
Current Good manufacturing practices.
Class
Medical device product classification is designated under 21 CFR Parts 862-892. A device’s class—of which there are three—is based on the risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Generally, Class I devices pose the lowest risk to a patient and/or user while Class II devices pose the highest risk.
Cleared
Medical devices are not “approved” through the 510(k) pathway, instead they are “cleared” by the FDA.
Combination Products
A product or products that combine a medical device plus another FDA-regulated product (e.g.,. prescription drug).
De Novo
An alternate pathway to classify a novel medical device that had automatically been placed in Class II after receiving an NSE determination in response to a premarket notification submission. This classification was added as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Device Description
Description customary includes an overall description of the device design, materials, energy sources and other key technological features.
DFUF
Device Facility User Fee.
DI
Device Identifier.
DoC
Declaration of Conformity.
DRLM
Device Registration and Listing Module.
EMC
Electromagnetic Compatability.
eSTAR
Electronic Submission Template and Resource.
FD&C Act | FDCA | FFDCA
Federal Food, Drug and Cosmetic Act.
FDA | USFDA
United States Food and Drug Administration
FURLS
FDA Unified Registration and Listing Systems.
GUDID
Global Unique Device Identification Database. Database administered by the FDA with the purpose of serving as a reference catalog for every device with a UDI. GUDID does not include product identifiers (ID); only the device identifier (DI) portion of the UDI is included in GUDID.
HDE
Humanitarian Device Exemption. HDE provides a possible route to market medical devices that may help people with a rare diseases or conditions.
HUD
Humanitarian Use Device.
IDE
Investigational Device Exemption. An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data
IFU
Instructions for Use.
Indications for Use
As defined in 21 CFR 814.20(b)(3)(i), describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.
Intended Use
General purpose of the device or its function, and encompasses the indications for use.
IVDs
In Vitro Diagnostics. IVD products can detect disease or other conditions and can be used to monitor a person’s overall health. IVDs may also be used in prevision medicine to identify patients who are likely to benefit from specific treatments or therapies. Examples include test kits and blood glucose meters.
J …waiting for suggestions!
K …waiting for suggestions!
L …waiting for suggestions!
MDDTs
Medical Device Development Tools.
Medical Device
Defined per Section 201(h) of the FD&C Act.
Medical Implants | Implants
Medical implants are devices or tissues that are placed inside or on the surface of the body.
MDUFA
Medical Device User Fee Amendments. There have been several amendments.
MDUFMA
Medical Device User Fee and Modernization Act of 2002.
MMAs
Mobile Medical Applications. MMAs are medical devices that are mobile apps, meet the definition of a medical device, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.
NEST
National Evaluation System for health Technology. The intended product of a collaboration between the FDA and medical device stakeholders to more efficiently generate better evidence for medical device evaluation and regulatory decision-making.
NSE
Not Substantially Equivalent. An FDA determination in response to a premarket notification submission.
OCP
Office of Combination Product. This FDA office assists with the application process for combination products.
OOPD
Office of Orphan Products Development.
PDP
Product Development Protocol.
PI
Production Identifier.
PMA
Premarket Approval. The FDA process of scientific and regulatory review of Class III medical devices. PMA approval is based on a determination by the FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
Postamendents Device
A device that was not available on the market prior to the Medical Device Amendments to the FD&C Act was signed into law in 1976. Typically, these devices are automatically classified as Class III devices. A postamendments device may be reclassified according to the process described in 513(f)(3) of the FD&C Act.
Preamendments Device
A device that was in commercial distribution prior to May 28, 1976 when the Medical Device Amendments to the FD&C Act was signed into law. A preamendments device could have been initially classified as Class I, II or III but can be reclassified as described in section 513(e) of the FD&C Act.
Predicate
A legally marketed device that was previously cleared through the 510(k) process and used for comparison to a new device for the purpose of determining substantial equivalence.
Premarket Notification 510(k)
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). See Traditional 510(k); Abbreviated 510(k); and Special 510(k).
Pre-Sub
Pre-Submission. It is an opportunity to obtain FDA feedback prior to an intended submission of a 510(k) application. The process is voluntary and requires a formal written application.
PRS
Protocol Registration System.
Quality System Regulation
The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the FD&C Act.
QUIK Review Program
Quality in 510(k) Review Program
Radiation-Emittting Electronic Products
Defined in section 531 of the FD&C Act. A product that, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits electronic product radiation. Radiation-emitting products with medical applications or medical claims are typically recognized as medical devices.
RASE
Reasonable Assurance of Safety and Effectiveness.
Recognized Consensus Standards
A voluntary program that is intended to simplify and streamline the 510(k) review process. Sponsors of devices can only declare conformance to the FDA recognized consensus standards and must document the extent of conformance in the 510(k) application.
RTA
Refuse to Accept.
S&P Based Pathway
Safety and Performance Based Pathway. A voluntary 510(k) pathway for well-understood Class II devices that meet specified performance criteria.
SaMD
Software as a Medical Device. Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Special 510(k)
Device modification to manufacturer’s own legally marketed device. The modification does not affect the intended use or fundamental scientific technoloy. No data is evaluated by the FDA.
Substantial Equivalence | SE
A device is substantially equivalent if, in comparison to a predicate it: (1) has the same intended use as the predicate; and has the same technological characteristics as the predicate; or (2) has the same intended use as the predicate; and has different technological characteristics and does not raise different questions of safety and effectiveness; and the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.
Third Party Review Organization | 3P510k | AP Program
FDA's implementation of section 523 establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P510k Review Program within the Center for Devices and Radiological Health (CDRH).
Traditional 510(k)
Relies on the demonstration of substantial equivalence to a predicate device.
UDI
Unique Device Identification System. Identifies medical devices sold in the US from manufacturing through distribution to patient use.
V & V
Verification and Validation.
VSE
Valid Scientific Evidence. May be used to establish the probable benefits and risks of a device.
W …waiting for suggestions!