US FDA Medical Device Recalls(21 CFR 7 & 810) ,Corrections and Removals (21 CFR 806)

 Voluntary Recall (21 CFR 7)

Manufacturers and distributors shall recall their products if their device present a risk of injury or gross deception or are otherwise defective.

The below figure provides the recall definitions,

Voluntary recall steps are given below,

Recall classification is given below,

Mandatory Device Recalls (21 CFR 810)

1.       Firm not initiated recall when device present a risk of injury or gross deception or are otherwise defective.

2.       FDA issue a recall order to the manufacturer

3.       FDA provide the opportunity for a regulatory hearing in order to modify or amend

4.       If the device present risk to health then FDA may issue a cease distribution and notification order requiring the person named in the order to immediately 

Mandatory Device Recalls (21 CFR 810)

1.       Firm not initiated recall when device present a risk of injury or gross deception or are otherwise defective.

2.       FDA issue a recall order to the manufacturer

3.       FDA provide the opportunity for a regulatory hearing in order to modify or amend

4.       If the device present risk to health then FDA may issue a cease distribution and notification order requiring the person named in the order to immediately

Corrections and Removals (21 CFR 806)

Manufacturer must report to FDA if they make any correction or removal to reduce a risk to health posed by the device . Reports of corrections and removals are required for Class I and Class II recalls.

When to submit to FDA: Within 10 working days from the time the firm initiates the correction or removal.

Manufacturer can submit electronically using  FDA Electronic Submission Software (eSubmitter) or e-mail.

Exceptions:

• If the  information already shared to FDA under Medical Device Reporting (21 CFR 803))
• If the recall was initiated by an FDA order under Medical Device Recall Authority (21 CFR 810)
• Market withdrawals
• Routine servicing, and
• Stock recoveries.

References:

Medical Device Recalls: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

US FDA Complaints and 21 CFR 803 Medical Device Reporting

 21 CFR 820.3(b): Complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”

The below figure shows the complaints handling process,

Section 519 of Food, Drug and Cosmetic Act & 21 CFR 803 Medical device Reporting.

21 CFR 803(o) MDR reportable event (or reportable event):

 An event that reasonably suggests that devices:

(i) May have caused or contributed to a death or serious injury, or

(ii) Has malfunctioned and to cause or contribute to a death or serious injury if the malfunction were to recur.

21 CFR 803(k) Malfunction:

Failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device.

21 CFR 803(W)) Serious injury:

 an injury or illness that:

(1) Is life-threatening,

(2) Results in permanent impairment of a body function or permanent damage to a body structure, or

(3) Necessitates medical or surgical intervention

Mandatory Reporters:

1.Manufacturers shall report the following to FDA through electronic MDR using electronic submission gateway(ESG)

·       30 day reports of deaths, serious injuries and malfunctions

·       5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health

Voluntary Malfunction Summary Reporting Program: As of August 2018, Some of manufacturers may be eligible submit summary reports of medical device adverse events on a quarterly basis to the FDA.Some cases this summary reporting cannot be used(Example new type of reportable malfunction) .

You can determine the Voluntary malfunction summary reporting device eligibility in Product classification database.

2.Distributor shall report the following to FDA and/or manufacturer through electronic MDR using electronic submission gateway(ESG).They have to report within 30 calendar days of becoming aware of an event

·       Reports of deaths and serious injuries (Both FDA and Manufacturer)

·       Reports of malfunctions(Only Manufacturer)

2. Device User Facility (Examples-hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility) shall report the following to FDA and/or manufacturer through Form FDA 3500A .They have to report within 30 calendar days of becoming aware of an event

·       Device-related Death (Both FDA and Manufacturer)

·       Device-related Serious injury (Only Manufacturer)

User Facility shall submit the annual summary of death & serious injury reports to FDA (January 1 for the preceding year)

Voluntary reporters (health care professionals, patients, caregivers and consumers)

• Report using  MedWatch

Manufacturer and User Facility Device Experience Database - (MAUDE)

• Contains device specific mandatory and voluntary medical device reporting information

MDRs are used to identify:

·       CAPA

·       Device recall

·       Notice to public (Safety communications)

References

Medical Device Reporting (MDR): How to Report Medical Device Problems

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#overview

MAUDE database

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Product classification database

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

 

 

 

US FDA Labelling 21 CFR 801 & 809

 Label vs labelling

Section 201(k) defines 'label' as a:	Section 201(m) defines 'labeling' as:
'display of written, printed, or graphic matter upon the immediate container of any article...'	'all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce
The term 'immediate container' does not include package liners.  Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper,   if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.'	The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc.  'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

 

21 CFR 801 General Device Labelling

21 CFR 801.1:The following must be included on the package label 

– Name and place of manufacturer, packer or distributor

– Including the street address, city, state and zip code

21 CFR 801.5: Adequate directions for use under which the layman can use a device safely for intended purposes

21 CFR 801.15: Required information must be displayed prominently on label. Exempted where device labelling lacks sufficient space.

All labeling shall be in English with the exception of products distributed solely within Puerto Rico or a U.S. territory where the predominant Ianuage is other than English.

21 CFR 801.109: A prescription device is exempt from “adequate directions for use”, provided:

– Device is in possession of a licensed practitioner

– Labeling has a Rx statement

– Labeling includes information for use

– Common use is known to the ordinary individual

Subpart H - Special Requirements for Specific Devices
21 CFR  801.15 Symbols used in labelling.

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In Vitro Diagnostic Products - 21 CFR Part 809 

LABEL REQUIREMENTS FOR THE IMMEDIATE CONTAINER

The label for IVD's must state the following information, except in cases where it is

not applicable.

·       The established and proprietary names of the product, e.g., cholestrolometers;

·       The intended use or uses, e.g., pregnancy detection, diabetes screening, etc.

·       A statement of warnings or precautions for users listed in 16 CFR part 1500 (hazardous substances) and any other warnings appropriate to user hazards, and a

statement "For In Vitro Diagnostic Use;"

·       Name and place of business of the manufacturer, packer, or distributor

·       Lot or control number

For Reagents:

·       Established (common or usual) name;

·       Quantity, proportion, or concentration of all active ingredients:

·        Storage instructions, i.e., temperature, humidity, etc.

·       Instructions for manipulation of products requiring mixing or reconstitution

·       Means to assure that the product meets appropriate standards of purity, quality,etc., at the time of use, including one or more of the following:

·       expiration date (date beyond which the product is not to be used);

·       statement of any visual indication of alteration;

·       instructions for a simple check to assure product usefulness;

·       The net quantity of contents.

If the immediate containers are too small, or no sufficient space, then the required labeling as listed above with blue text may appear on the outer container labeling only.

 

LABELING REQUIREMENTS FOR INSERTS AND OUTER PACKAGING [809.10(B)]

·       The proprietary and established product name;

·       The intended use of the product and whether it is a qualitative or quantitative

type of procedure, e. g., screening, physician's office, home use, etc.

·       Summary and explanation of the test, including a short history containing methodology and the special merits and limitations of the test

·       The chemical, physical, physiological, or biological principles of the procedure

For Reagents:

·       The common name, if any, and quantity, proportion, or concentration or each

·       reactive ingredient; and for biological materiar, the source and measure of its activity.

·       Appropriate cautions or warnings listed in 16 CFR Part 1500; the statement: "For

In Vitro Diagnostic Use;" and any other limiting statements appropriate to the intended use of the product;

·       Adequate directions for reconstitution, mixing, dilution, etc.

·       Appropriate storage instructions

·       A statement of purification or treatment required for use; and

·       Physical, biological, or chemical indications of instability or deterioration.

For Instruments:

·       Use or function.

·       Installation procedures and requirements

·       Principles of operation

·       Performance characteristics and specifications

·       Operating instructions

·       Calibration procedures, including equipment and or materials

·       Operational precautions and limitations

·       Hazards

·       Service and maintenance information.

Specimen collection and preparation for analysis, describing:

·       Special precautions/preparations

·       Additives necessary to maintain specimen integrity

·       Known interfering substances; and

·       Recommended specimen storage, handling, and shipping instructions

·       Explanation of the procedure

·       Limitations of the procedure

·       Expected values including the range and how it was established

·       Specific performance characteristics as appropriate including accuracy, specificity,

·       precision, and sensitivity

·       Bibliography

·       Name and place of business of the manufacturer, packer, or distributor

Premarket submissions 510(k) ,IDE and PMA have specific labelling requirements.

 Electronic labelling applicable for Prescription devices (Section 206 of Medical Device User Fee and

Modernization Act (MDUFMA))

References:

Device Labeling:

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

Labeling - Regulatory Requirements forMedical Devices