Medical Device Regulation Basics: US FDA Regulatory Controls

General controls

All US medical devices shall follow General controls. For class I devices general control itself sufficient to provide the safety and performance.

Some of the general controls are provided below,

Adulteration

· FD&C Act 501

· Provide device not proper for use

Device is adulterated on below conditions,

Includes any filthy, putrid, or decomposed substance
It is prepared, packed, or held under unsanitary conditions
Consists of any poisonous or deleterious substance
Consists of any unsafe color additive
Claimed device strength or its purity or quality falls or differs
Noncompliance of any performance standard (if applicable)
Class III: Noncompliance of approved premarket approval application or a notice of completion of a product development protocol
Banned device
Any violation of good manufacturing practice requirements
Fails to comply with an Investigational Device Exemption (IDE)

Misbranding

· FD&C Act 502

Device is misbranded on below conditions,

· Its labeling is false and misleading.

· Packaging label doesn’t not contain below,

o the name of the place of business of the manufacturer, packer, or distributor, and

o quantity of contents in terms of weight, measure, or numerical count.

Exemptions for small packages may be permitted.

Labelling is not readily understood by individual under customary conditions of purchase and use. Some of the required information is missing.
Use of any narcotic or habit-forming substance. This is not mentioned in label (name and quantity or proportion of the substance or derivative and the statement "Warning - may be habit forming").
Its label does not bear adequate directions for use. The label must include warnings against use in certain pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. Adequate directions and warnings must be present when it is necessary to protect the health of the user. Exemptions to this provision may be obtained. The phrase "adequate directions for use" pertains to over-the-counter drugs and device.
It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.
Non Compliance of color additive provisions listed under Section 706 of the FD&C Act.
The device's established name or common or usual name, is not prominently printed in type at least half as large as that used for any proprietary name or designation. Exemptions from this provision may be granted
Restricted device uses false or misleading advertising
Restricted device sold, distributed, or used in violation of restricted device regulations under Section 820(e) of the FD&C Act

· Device commercially distributed without FDA concurrence on a Section 510(k) submission

Restricted device manufacturer fails to include in advertisements or other descriptive materials:

1. a true statement of the device's established name, prominently printed, and

2. a brief statement of the intended uses of the devices and relevant warnings, precautions, side effects, and contradictions.

Device doesn’t bear or comply labelling per performance standard (if applicable)

· Failure or refusal to comply below,

o Requirement prescribed under section 518 (Notification and Other Remedies)

o to furnish any material or information required by or under Section 518

o to furnish any material or information requested by or under Section 519 (Records and Reports on Devices).

Banned Devices

Section 516 of the FD&C Act authorizes the Agency to ban devices that present substantial deception or unreasonable and substantial risk of illness or injury.

Device presents deception or risk of illness or injury---Agency determines ---Change in labelling shall not help in correction of the deception or risk of illness or injury---Agency may proposed regulation to ban the device in the Federal Register

Device presents deception or risk of illness or injury---Agency determines ---Change in labelling helps in correction of the deception or risk of illness or injury---Agency notify the responsible person of the deception or risk, the change in labeling needed to correct it, and the time period within which the change should be made--- If the labeling is not changed in the specified time and manner, then the Agency may publish the proposed regulation

Agency will affirm, modify, or revoke the proposed regulation based on informal hearing on the proposal from all interested persons.

Once final regulation published ,device can no longer be legally marketed on and after the date of publication of the final regulation, except under an approved investigational device exemption.

If the proposed regulation is revoked, the Agency will publish a notice to this effect in the Federal Register.

Restricted devices

Under the provision of Section 520(e) of the Amendments, the FDA is authorized to restrict the sale, distribution, or use of a device if there cannot otherwise be reasonable assurance of its safety and effectiveness. A restricted device can only be sold on oral or written authorization by a licensed practitioner or under conditions specified by regulation.

Other general controls include Labeling, Medical Device Reporting, Establishment Registration, Device Listing, Quality System.

Click here to know more about Establishment Registration & Device Listing

Click here to know more about Labelling

Click here to know more about Complaints and Medical Device Reporting

Click here to know more about Quality System

Special Controls

Regulatory requirements for class II devices.

Special controls are usually device-specific and include: