Description

PMA is 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.

The database contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about the applications and receipt and decision dates. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. An approved PMA Application is, in effect, a private license granted to the applicant for marketing a particular medical device.

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.

Data Source

U.S. Food and Drug Administration (fda)

Data Coverage

• Time period: 1976 to present

Update Frequency

• This dataset is updated every month.

Data Fields

advisory_committee

This equates to the review division within CDRH in which the PMA would be reviewed, if it were reviewed today; this is derived from the procode and is always same as the “Review Panel” field in the Device Classification database (e.g. GU).

Value is one of the following

• AN = Anesthesiology
• CV = Cardiovascular
• CH = Clinical Chemistry
• DE = Dental
• EN = Ear, Nose, Throat
• GU = Gastroenterology, Urology
• HO = General Hospital
• HE = Hematology
• IM = Immunology
• MI = Microbiology
• NE = Neurology
• OB = Obstetrics/Gynecology
• OP = Ophthalmic
• OR = Orthopedic
• PA = Pathology
• PM = Physical Medicine
• RA = Radiology
• SU = General, Plastic Surgery
• TX = Clinical Toxicology

advisory_committee_description

Full spelling of the Advisory committee abbreviation (e.g. gastroenterology).

ao_statement

Approval order statement: a brief description of the reason for the supplement/application approval by FDA.

generic_name

Common or generic name as specified in the submission. Not to be confused with the official device nomenclature name related to the product code.

supplement_number

FDA assigned supplement number.

supplement_reason

General description for the reason for the supplement or application.

supplement_type

Link to general criteria used for PMA regulation (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814). The “PMA regulation” (21 CFR Part 814) sets forth general criteria for determining when you must submit a PMA supplement or a 30-day notice for a device modification or manufacturing change (21 CFR 814.39).

trade_name

This is the proprietary name of the approved device.

decision_date

fed_reg_notice_date

Documentation forthcoming.

date_received

Date that the FDA Document Control Center received the submission.

decision_code

A four digit code reflecting the final decision for a PMA submission.

Value is one of the following

APPR = Approval: PMA has been approved.

WTDR = Withdrawal: PMA has been withdrawn.

DENY = Denial: PMA has been denied.

LE30 = 30 day notice acceptance (decision made in ≤30 days).

APRL = Reclassification after approval.

APWD = Withdrawal after approval.

GT30 = No decision made in 30 days.

APCV = Conversion after approval.

product_code

A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time.

pma_number

FDA-assigned premarket application number, including leading letters. Leading letter “D” indicates Product Development Protocol type of Premarket Approval. Leading letters “BP” indicates Premarket Approval by Center for Biologics Evaluation and Research. Leading letter “H” indicates Humanitarian Device Exemption approval. Leading letter “N” indicates New Drug Application. Early PMAs were approved as NDAs. Leading letter “P” indicates Premarket Approval.

docket_number

The assigned posted docket number in the Federal Register.

expedited_review_flag

Flag indicating that the approval review process was expedited.

Value is one of the following

Y = Yes

N = No

applicant

The manufacturer of record or third party who submits a PMA submission for clearance (also known as sponsor).

This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

device_class

A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)

Value is one of the following

1 = Class I (low to moderate risk): general controls

2 = Class II (moderate to high risk): general controls and special controls

3 = Class III (high risk): general controls and Premarket Approval (PMA)

U = Unclassified

N = Not classified

F = HDE

device name

This is the proprietary name, or trade name, of the cleared device.

fei_number

Facility identifier assigned to facility by the FDA Office of Regulatory Affairs.

medical_specialty_description

Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field.

regulation_number

The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device.