US FDA Establishment Registration & Device Listing

 21 CFR Part 807

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.

These establishments also necessity to list their devices including premarket submission number (510(k), De Novo, PMA, PDP, HDE).

Registration and listing provide FDA with the location of medical device manufacturing facilities and the list of devices manufactured.

Who Is Required To Register and List

Establishment Type: Domestic /Foreign	Activity	Register	List
Domestic  and Foreign	Manufacturer / Remanufacturer / Kit Assemblers	Yes	Yes
Domestic  and Foreign	Specification Developer	Yes	Yes
Domestic  and Foreign	Contract Manufacturer / Sterilizer	Yes	Yes
Domestic  and Foreign	Repackagers / Relabelers	Yes	Yes
Domestic  and Foreign	Reprocessors of Single Use Devices	Yes	Yes
Domestic  and Foreign	Complaint Handlers	Yes	Yes
Domestic	Initial Importers	Yes	No
Foreign	Foreign Exporter of devices located in a foreign country	Yes	Yes

 Exceptions for Registration & Listing

·       Device being investigated under IDE

·       Domestic Distributor that does not import devices

·       Refurbishers or remarketers of used devices already in commercial distribution in the United States.

·       Wholesale distributor that is not a manufacturer or importer

·       Manufacturer of components, that are not otherwise classified as a finished device, that are distributed only to a finished device manufacturer

·       Manufacturers whose devices are used solely in research, teaching, or analysis and not introduced into commercial distribution.

 

When to Register & List

Initial registration timelines are given below

Establishment Type Domestic /Foreign	Timelines
Domestic	Within 30 days of putting a device into commercial distribution
Foreign	Prior to exporting to the United States for the first time
Initial Importers	Prior to importing to the United States for the first time –only register; do no list –must identify the manufacturer of each device imported

 

All manufacturers shall register annually between October 1 through December 31 of each year.if there is any changes then reflect the same in registration and lisiting.

 Register the establishments electronically using FDA Unified Registration and Listing Systems (FURLS). FDA may grant the exception for electronic registration

Foreign establishments need United States agent for registration and listing.

Establishment registration requires establishment type, Owner Operator and Official Correspondent (name, address, phone, email, etc.)

Device listing require product code for the device ,type of activities performed by establishments and proprietary or brand names  and premarket submission number (510(k), De Novo, PMA, PDP, HDE).

 References:

Registration and Listing: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm

•Who Must Register, List and Pay Fee http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm

 

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:

• Performance standards
• Postmarket surveillance
• Patient registries
• Special labeling requirements
• Premarket data requirements
• Guidelines

 References

General controls for medical devices:

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

21 CFR : https://www.ecfr.gov/cgi-bin/text-idx?SID=2208a134b9c7751f96ebbb014ec55235&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

 

US FDA Medical Device Classification

 Medical devices are classified based on intended use and indications for use. There are 3 classes I, II and III. Below figure shows the US FDA risk-based device classification.

The following options are available for accessories class identification,

1. Accessory used with single/same device: Same class as the parent device

2. Accessory used with multiple device: Different class as the parent device

How to determine the device class:

You should know the intended use and technology of the device. Device should meet the definition per section 201(h) of the FD&C Act

Medical device classes are determined using product classification database or classification panels.

Product classification database:

·       Contains device names and their associated product codes.

·       Search using device type and product code.

Click here to access product classification database 

Classification Panels (CFR Parts 862-892) :

·       Devices are grouped in medical specialty "panels" such as Cardiovascular devices or Ear, Nose, and Throat devices.

·       1,700 distinct types of devices grouped into 16 medical specialty 

Click here to know more about classification panels.

If you are not sure about device class. The following ways you can determine the device classification.

Informal:

Contact the Division of Industry and Consumer Education (DICE) email-dice@fda.hhs.gov

Email the Device Determination experts (DeviceDetermination@fda.hhs.gov)

Include the following information in your email: CDRH will respond within 7 days

1.     Brief device description

2.     Clear intended use

3.     List or picture of all Labeling claims

Formal:

Submit a 513(g) Request:

The following information should be submitted

1.Cover Letter

·       Date of the request

·       Company name

·       Contact person

·       Contact information (email and phone number)

·       Device Name

·       Question(s) to FDA

2.Device Description

·       Brief description

·       Describe mechanism of action

·       Describe disease or condition the device is intended for

·       Include picture or schematic, if available

·       Patient population

3.Intended Use

·       Describe what the device is used for

·       Physiological purpose

4.Labeling Claims or Promotional claims beyond the intended use

FDA shall respond via email within 60 calendar days. It provides the letter including device class, regulatory pathway and guidance document.

Denovo Classification Request:

Applicable for novel devices. Process for the classification of certain low-risk devices for which there is no predicate

Click here to know more about Denovo Classification Request

References:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

21 CFR 

https://www.fda.gov/training-and-continuing-education/cdrh-learn

 

 

US FDA Device Defintion & Regulatory Authority

Federal Food Drug & Cosmetic (FD&C) Act section 201(h) have device definition.

A device is:

·   "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1.  recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

2.  intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man, or

3. intended to affect the structure or any function of the body of man, and which does not achieve its primary intended purposes through chemical action within or on the body of man and

which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

The term "device" does not include software functions excluded pursuant to section 520(o).

The following software functions are excluded from device definition,

·       Software Function Intended for Administrative Support of a Health Care Facility

·       Software Function Intended for Maintaining or Encouraging a Healthy Lifestyle

·       Software Function Intended to Serve as Electronic Patient Records

Click here to know more about software function which are excluded from device defintion.

Device definition includes In vitro diagnostic product (IVD).

Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]

Regulatory authority: FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

CDRH regulates the devices including (medical devices and IVDs).

IVDs are considered as biological products subject to section 351 of the Public Health Service Act. They are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.

Other Regulatory authority:

Center for Drug Evaluation and Research (CDER): Human drugs

 Center for Biologics Evaluation and Research (CBER): Biological products which include blood and blood products, and blood banking equipment

Center for Veterinary Medicine (CVM):Products used with animals

 

References:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

21 CFR