Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299.
1. Determine whether the product is a medical device or a radiation-emitting product as defined by the FD&C Act, or both.
2. Determine device classification
Device ClassificationMedical devices are assigned to one of three regulatory classes: Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness
3. Determine applicable regulatory controls
Product ClassificationA database including a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.
Device Registration and ListingManufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
Establishment Registration & Device Listing DatabaseIncludes medical device manufacturers registered with FDA and medical devices listed with FDA.
Choose the Correct Premarket Submission for your Medical Device
Premarket Notification 510(k) - 21 CFR Part 807 Subpart E
Premarket Notification 510(k)Required for all medical devices unless a premarket approval (PMA) is necessary, or the device is exempt and does not exceed the limitations of exemptions.
Premarket Approval (PMA) - 21 CFR Part 814
Premarket Approval (PMA)Necessary for Class III devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II.
Investigational Device Exemption (IDE) - 21CFR Part 812
Investigational Device Exemption (IDE)An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA.
Humanitarian Device Exemption
Humanitarian Device Exemption (HDE)Device that are intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
Evaluation of Automatic Class III Designation (De Novo) Summaries
De Novo ClassificationDe novo classification option is an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission
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Quality System Regulation (QS)/Good Manufacturing Practices (GMP)The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements
