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Medical Devices Flowchart

Medical-Device-flowchartDevice ClassificationOther FDA RequirementsDevice ClassificationExemptSubstantially EquivalentReclassification or de novo designationPremarket ApprovalPremarket NotificationFDA Letter Declaring Device Substantially EquivalentGood Manufacturing PracticesLabeling RequirementsEstablishment Registration and Device ListingMedical Device ReportingImport and ExportChanges to the Device

Other FDA requirements

If the product or material is not a medical device, consider whether it is subject to other FDA regulation, e.g., as a drug. Note that FDA's Center for Devices and Radiological Health (CDRH) regulates (in addition to medical devices) radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.

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Device classification

Devices are classified by finding the matching description in 21 CFR Parts 862-892. FDA has classified and described over 1,700 distinct types of devices and organized them into 16 medical specialty ''panels'' such as cardiovascular devices or ear, nose, and throat devices.

If you already know the appropriate panel, you can go directly to the CFR and find the classification for your device by reading through the list of classified devices. You can also try using the keyword directory or other search in FDA's product classification database

Each classified device has a 7-digit number associated with it that refers to its regulatory citation, e.g., 21 CFR 880.5075. Once you find your device in the panel's beginning list, go to the section indicated (e.g., 21 CFR 880.5075), which describes the device and provides its class.

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Exempt

Almost all Class I devices and a few Class II devices are exempt from the premarket notification requirements subject to the limitations on exemptions. Note that Class I and Class II devices are not exempt from other general controls.) Exemption status and limitations are set out in 21 CFR Parts 862-892, in the specific section for each device. FDA also maintains a web page with a table format list of Class I and Class II exempt devices.

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Substantially equivalent

A 510(k) requires demonstration of substantial equivalence to another device legally marketed in the U.S. A device is substantially equivalent if, in comparison to a predicate (the legally marketed device) it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate;

or

  • has the same intended use as the predicate; and
  • has different technological characteristics and the information submitted to FDA;
  • does not raise new questions of safety and effectiveness; and
  • demonstrates that the device is at least as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and/or other characteristics.

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Reclassification or de novo designation

FDA has procedures for reclassifying devices (e.g., from Class III to Class II. etc.). The petition process is set forth at 21 CFR 860 – Medical Device Classification Procedures.

A 510(k) submitter who receives a Not Substantially Equivalent (NSE) determination placing the device into a Class III category can request a de novo classification of the product into Class I or II. FDA has publishedguidance on the de novo process.

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Premarket Approval (PMA)

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and is the most stringent type of FDA device application. Consult FDA's web page on the PMA for additional information.

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Premarket Notification (510k)

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements. There is no 510(k) form—requirements are described at 21 CFR 807 Subpart E.

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FDA letter declaring device substantially equivalent

Before marketing a device, each submitter must receive an order, in the form of a letter, in which FDA finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order ''clears'' the device for commercial distribution.

If FDA determines that a device is not substantially equivalent, the applicant may:
  • resubmit another 510(k) with new data,
  • request a Class I or II designation through the de novo process
  • file a reclassification petition, or
  • submit a premarket approval application (PMA).

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Good manufacturing practices (GMPs)

The Quality System (QS)/Good Manufacturing Practices (GMP) regulations are at 21 CFR Part 820. The regulations include 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. FDA inspects manufacturing facilities to assure compliance with the requirements. A few Class I devices are exempt from the GMP requirements with the exception of complaint files and general recordkeeping requirements.

The regulation do not prescribe in detail how a manufacturer must produce a specific device, but rather provide a framework for developing appropriate procedures according to the current state-of-the-art manufacturing for the specific device. If you are considering manufacturing a device, you will need to develop an appropriate system in accordance with the QS/GMP regulations and FDA guidance.

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Labeling requirements

Labeling requirements for medical devices are found in FDA regulations on general device labeling and in specific regulations for in vitro diagnostic products, investigational devices, general electronic products, and QS/GMPs. The general labeling requirements address name and place of business, intended uses, directions for use, misleading statements, prominence of required statements, Spanish-language versions of certain required statements, and special requirements for specified devices. FDA provides guidance on its device labeling web page.

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Establishment registration and device listing

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments annually with the FDA, including payment of a fee. Most establishments that are required to register with the FDA are also required to list the devices made and the activities that are performed on those devices. Registration and listing information must be submitted annually between October 1st and December 31st. Detailed information is available on FDA's Device Registration and Listing web page.

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Medical device reporting (MDR)

FDA Medical Device Reporting (MDR) regulations require firms that have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify FDA. The Safe Medical Devices Act (SMDA) of 1990 provided FDA with two additional postmarketing activities: Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level. Additional information is available on FDA's web page on reporting adverse effects.

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Import and Export

Foreign manufacturers must meet applicable U.S. medical device regulations in order to import devices into the U.S., even if the product is authorized for marketing in another country. In addition, the initial importer of the device must register its establishment with FDA. Initial importers are also subject to Medical Device Reporting (MDR) under 21 CFR 803, Reports of Corrections and Removals under 21 CFR 806, and Medical Device Tracking under 21 CFR 821 

Any medical device that is legally in the U.S. may be exported without prior FDA notification or approval. There are requirements for exporting unapproved devices.

For additional information, consult FDA's web page on importing and exporting devices.

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Changes to the device

Any changes made to specifications or manufacturing processes for a device must be made in accordance with the Quality System regulations and may be subject to a new 510(k). This could include changes in labeling, technology or performance, or materials. 

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