30-day PMA supplement - a supplemental application to an approved PMA in accordance with 21 CFR 814.39(e).
Act - Federal Food, Drug, and Cosmetic Act (sections 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392).
Agency - U.S. Food and Drug Administration
CFR - Code of Federal Regulations
Federal Register (FR) - Publication of the federal government to establish new regulations or to change existing regulations.
FDA - U.S. Food and Drug Administration
GMP - Good Manufacturing Practices, also referred to as Quality System under 21 CFR 820
Humanitarian Device Exemption (HDE) - a premarket approval application submitted under 21 CFR 814 Subpart H seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2) of the Act.
Humanitarian Use Device (HUD) - a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
IDE - an approved or considered approved Investigational Device Exemption under 21 CFR 812 and section 520(g) of the FD&C Act.
Master file - a reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.
Medical Device Amendment - an amendment to the Food, Drug, and Cosmetic Act signed into law on May 28, 1976. The amendments gave FDA authority to regulate medical devices.
Office of Communication and Education (OCE) - The office of FDA/CDRH that communicates risk and benefit information about medical devices and radiation-emitting electronic products by developing and facilitating public communication, educating the industry we regulate, and providing CDRH employees with the information and training they need to be successful.
Office of Health Technology 7: Office of In Vitro Diagnostics and Radiological Health (OHT7) - The office of FDA/CDRH that consolidates all regulatory activities for in vitro diagnostics and radiological medical devices, along with electronic product radiation control responsibilities and leadership of the Mammography Quality Program.
Office of Regulatory Affairs (ORA) - The Office of Regulatory Affairs is responsible for facility inspections of FDA regulated establishments. ORA employees are located in FDA headquarter offices and in more than 150 offices throughout the U.S.
Office of Product Evaluation and Quality (OPEQ): OPEQ is responsible for most of the day-to-day regulatory activities for the Center, spanning the full spectrum of the total product life cycle. OPEQ features an immediate office, seven Offices of Health Technology, the Office of Regulatory Programs, and the Office of Clinical Evidence and Analysis.
Offices of Health Technology: OPEQ features seven Offices of Health Technology (OHTs). Each OHT covers a specific product area. Each OHT is responsible for the total product life cycle review, that is, premarket, compliance and quality, surveillance, of its particular program area and leading the development of policy in its respective product area.
PMA - any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference. "PMA" includes a new drug application for a device under section 520(l) of the FD&C Act.
PMA amendment - information an applicant submits to FDA to modify a pending PMA or a pending PMA supplement.
PMA supplement - a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference.
Person - any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or any other legal entity.
Postamendment device - a device that is commercially distributed on or after May 28, 1976, the date the Medical Device Amendments of 1976 were signed into law.
Preamendment device - a device that was commercially distributed before May 28, 1976, the date of the Medical Device Amendments of 1976 were signed into law.
QS - Quality System, 21 CFR 820
Reasonable probability - that it is more likely than not that an event will occur.
Serious, adverse health consequences - any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.
Statement of material fact - a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect.
Trade Name - an established product name under which each device is marketed. The trade names are used in a product’s labels and labeling as well as in other promotional materials. Proprietary name is a commercial name created by a naming authority for use in marketing a drug/device product in a particular jurisdiction.
Transitional Devices - Transitional devices are devices that were regulated as drugs prior to the May 28, 1976, the date the Medical Device Amendments were signed into law. Any device that was approved by the New Drug Application process is now governed by the PMA regulations. The original NDA approval number is maintained.