Overview: FDA Regulation of Medical Devices

The following information is provided as general guidance to the Food and Drug Administration (FDA) regulation of medical devices. The Center for Devices and Radiological Health (CDRH) is the division of FDA responsible for medical device regulation. CDRH maintains a very informative web site. The CDRH web site is located at: http://www.fda.gov/cdrh/devadvice/default.htm.

For support in working with the FDA and applicable regulations/interpretation, contact:

Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
E-mail: QRASupport@AOL.com
Phone: 608 877-2635
Fax: 608 873-7382
http://www.qrasupport.com



Many of the regulations enforced by the Food and Drug Administration (FDA) with regard to medical devices can be found in Title 21 Code of Federal Regulations (CFR) Part 800 to Part 1299. This reference is abbreviated to 21 CFR 800 to 1299.


Medical Device Definition

A medical device is defined within the Food Drug & Cosmetic Act as "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Medical devices distributed in the United Sates are subject to General Controls, pre-marketing and post marketing regulatory controls.

General Controls include:

  1. Establishment Registration by manufacturers, distributors, repackages and re-labelers,
  2. Medical Device Listing with FDA of devices to be marketed,
  3. Manufacturing the devices in accordance with Good Manufacturing Practices,
  4. Labeling medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809,
  5. Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medial device.

Pre-marketing controls are device and device classification specific. Pre-marketing controls for a medical device may include: clearance to market by 510(k) or approval to market by Pre-Market Approval (PMA). Post marketing controls include Device Listing, Medical Device Reporting (MDR), Establishment Registration and Quality System Compliance Inspection.

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Device Classification

There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risk to the patient and FDA regulatory control increase. Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device.

The FDA classification of medical devices is based upon classifications for devices currently legally marketed in the United States. The FDA determines the device classification by the device intended use and risk the device presents to the patient. New medical devices are compared to legally marketed medical device classifications with the same intended use and technological characteristics to determine the device classification.

Class I medical devices have the least amount of regulatory control. Class I devices present minimal potential harm to the user. Class I devices are typically simple in design, manufacture and have a history of safe use. Examples of Class I devices include tongue depressors, arm slings, and hand-held surgical instruments. Most Class I devices are exempt from the premarket notification and may be exempt from compliance with the good manufacturing practices regulation.

Class II medical devices are devices where General Controls are not sufficient to assure safety and effectiveness and existing methods/standards/guidance documents are available to provide assurances of safety and effectiveness. In addition to compliance with General Controls, Class II devices are required to comply with Special Controls. Special Controls include:

Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. A few Class II devices are exempt from the premarket notification. Information on Class II exempt devices is located within the device regulation, 21 CFR 862 through 892. Examples of Class II devices include physiologic monitors, x-ray systems, gas analyzers, pumps, and surgical drapes.

Class III medical devices have the most stringent regulatory controls. For Class III medical devices, sufficient information is not available to assure safety and effectiveness through the application of General Controls and Special Controls. Class III devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Typically a Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a Class III medical device. A few Class III medical devices are required to only have a 510(k) cleared by the FDA to be marketed. Examples of Class III devices that require a PMA are: replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.

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510(k) Clearance to Market

The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.

The information required in a 510(k) submission is defined 21 CFR 807.87. A 510(k) submission includes:

Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.

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PMA (Pre-Market Approval)

A PMA is required for FDA Approval of medical devices that present significant risk to the patient and/or require significant scientific review of the safety and effectiveness of the medical device prior to commercial introduction. Most Class III medical devices require a PMA. Section 515(c)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) specifies the required contents of a PMA. PMA application content includes:

The FDA has a statutory 180-day review cycle for PMA applications. Often PMA applications require medical advisory board review prior to the FDA granting approval to market the medical device. A facility inspection verifying the manufacturing systems present to manufacture the medical device is usually performed prior to FDA PMA approval. FDA approval of a PMA often requires significantly more than 180 days.

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Good Manufacturing Compliance(GMP)Compliance

The Good Manufacturing Practice (GMP) requirements are defined in 21 CFR 820. The GMP is also referred to as the Quality System (QS) Regulation. A quality system is required for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The QS Regulation is similar to ISO 9001:1994, with FDA particular requirements. The QS Regulation covers:

The FDA may audit the manufacturing facility for GMP compliance every 2 years. FDA compliance inspections are based upon results of prior audits, device risks, recall of devices and FDA initiatives in regard to particular classifications of devices.

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Establishment Registration

Establishments involved in the production and distribution of medical devices intended for marketing in the United States are required to register with the FDA. Establishment Registration requirements are defined in 21 CFR 807. Establishment Registrations are verified and updated annually.

Foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported, or offered for import, into the United States must register their establishments and provide the FDA with the name of the United States agent representing their establishment. Foreign establishments must provide FDA with a list of the devices that they are exporting to the United States.

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Device Listing

Most medical device establishments required to register with FDA must list the devices they have in commercial distribution. Medical device listing is completed by the classification name the FDA has assigned to the medical device, see 21 CFR Part 862 to 892.

Device listing should be completed within 30 days of entering a device into commercial distribution in the United States. Device listing is updated when a new classification of device is entered into commercial distribution, the marketing of a device classification is discontinued, or marketing of a discontinued device is started again.


Medical Device Reporting(MDR)

The Medical Device Reporting (MDR) regulation requires firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The requirements for medical device reporting are defined in 21 CFR 803. The regulation requires:


For support in working with the FDA and applicable regulations/interpretation, contact:

Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589
E-mail: QRASupport@AOL.com
Phone: 608 877-2635
Fax: 608 873-7382
http://www.qrasupport.com

Go back to QRA Home Page


Updated: May 6, 2003