Overview: FDA Regulation of Medical Devices

Medical Device Definition

Medical Device Recalls are either corrections or removals, depending on where the action is applied. The FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

Despite the great care taken during the development of medical devices, errors can still occur. The important thing, therefore, is to establish proactive practices to determine ‘recall readiness’ after launching of a medical device product. To explore the impact of managing the decision-making process of a recall (if you ever have to face one), Read More>>

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:

1. Clearance to market by 510(k),

2. Approval to market by Pre-Market Approval (PMA)

3. Post marketing controls include Device Listing

4. Medical Device Reporting (MDR)

5. Establishment Registration and Quality System Compliance Inspection

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 increases. 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:

  • Special labeling requirements,
  • Mandatory performance standards, both International and United States
  • Postmarket surveillance
  • FDA medical device specific guidance

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.

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:

  • Device trade or proprietary name, common or usual name or classification, Class of the device (Class I, II, III)
  • Submitter’s name and address, Contact person, telephone number and fax number, Representative/Consultant if applicable
  • Name and address of manufacturing/packaging/sterilization facilities, Registration number of each manufacturing facility
  • Action taken to comply with the requirements of the Special Controls.
  • Proposed labels, labeling, and advertisements to describe the device, its intended use, and the directions for its use.
  • 510(k) summary or a 510(k) statement.
  • For Class III medical device, a Class III certification and a Class III summary.
  • Photographs of the device, Engineering drawings of the device.
  • Identification of the marketed device(s) to which equivalence is claimed including labeling and description of the medical device.
  • Statement of similarities and/or differences with marketed device(s)
  • Data to show consequences and effects of a modified device, performance Data (bench, animal, clinical)
  • Sterilization information (as applicable)
  • Software development, verification and validation information
  • Hardware design and development information
  • Information requested in specific guidance documents (as applicable)
  • Kit Certification Statement (for a 510(k) submission with kit components only)
  • Truthful and Accurate Statement

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.

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:

  • full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;
  • a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;
  • a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of such device;
  • an identifying reference to any performance standard under Section 514 which would be applicable to any aspect of such device if it were a Class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standards;
  • such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing;
  • specimens of the labeling proposed to be used for such device; and
  • such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under Section 513, may require.

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. Risk evaluation and development of mitigation strategies
Read More>>

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:

  • quality management and organization,
  • device design,
  • buildings,
  • equipment,
  • purchase and handling of components,
  • production and process controls,
  • packaging and labeling control,
  • device evaluation,
  • distribution,
  • installation,
  • complaint handling,
  • servicing,
  • records.

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.

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.

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:

  • A written MDR procedure,
  • MDR event files,
  • Individual adverse event reports,
  • 5 day MDR reports of remedial action taken to prevent unreasonable risk of substantial harm to public health,
  • 30-day MDR reports of deaths, serious injuries and malfunction attributed to the medical device,
  • Baseline reports for the medical device.

Risk evaluation and development of mitigation strategies

Read More>>

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