US FDA Quality System Regulation(QSR) 21 CFR 820

 Medical device manufacturer shall follow Current good manufacturing practice (CGMP) requirements to produce their medical devices.

Subpart B - Quality System Requirements

Sec. 820.20 Management responsibility.

Each manufacturer shall establish and maintain procedures for (a)    Quality policy. (b)    Organization. a.       Responsibility and authority. b.       Provide adequate resources c.       Appoint managment representative (c)     Management review (d)    Quality planning (e)    Quality system procedures.

Sec. 820.22 Quality audit.

Each manufacturer shall establish procedures for quality audits and conduct such audits

Sec. 820.25 Personnel.

Each manufacturer shall have adequate personnel with the necessary education, training etc to perform his activities correctly.

Subpart C - Design Controls

(a)    General Applicable for all Class II & III and some of Class I devices

(b)    Design and development planning (c)     Design input (d)    Design output (e)    Design review (f)      Design verification (g)    Design validation (h)    Design transfer (i)      Design changes (j)      Design history file(DHF)

Subpart D - Document Controls

Each manufacturer shall establish and maintain procedures to (a)    Document review, approval and distribution (b)    Document changes

Subpart E - Purchasing Controls Purchased product or received product shall conform to specific requirements

Sec. 820.50 Purchasing controls.

(a)    Evaluation of suppliers, contractors, and consultants (b)    Purchasing data

Subpart F - Identification and Traceability Identify and trace the product during all stages

Subpart G - Production and Process Controls Production processes of a device shall conforms to specifications

(a)    General (b)    Production and process changes (c)     Environmental control (d)    Personnel (e)    Contamination control (f)      Buildings (g)    Equipment(Manintenance,inspection and adjust^ment (h)    Manufacturing material (i)      Automated processes

Sec. 820.72 Inspection, measuring, and test equipment. Including calibration

Sec. 820.75 Process validation. 21 CFR 820.3 (z)(1)establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Process shall be validated when the results of a process cannot be fully verified by subsequent inspection and test.

Subpart H - Acceptance Activities Establish and maintain procedures for inspections, tests, or other verification activities.

Sec. 820.80 Receiving, in-process, and finished device acceptance.

(a)    General (b)    Receiving acceptance activities (c)     In-process acceptance activities (d)    Final acceptance activities (e)    Acceptance records-Part of DHR

Sec. 820.86 Acceptance status.

Subpart I - Nonconforming Product

Sec. 820.90 Nonconforming product.

(a)    Control of Nonconforming product (b)    Nonconforming product (c)     Rework (retesting and reevaluation) of Nonconforming product -Part of DHR

Subpart J - Corrective and Preventive Action

Sec. 820.100 Corrective and preventive action.

(a)    Establish and maintain procedures for implementing corrective and preventive action a.       Analyze the process b.       Investigate the cause c.       Identify the action to correct d.       Verify and validate the action (b)    All the results shall be documented

Subpart K - Labeling and Packaging Control

Sec. 820.120 Device labeling.

(a)    Label integrity (b)    Labeling inspection (c)     labelling storage (d)    Labelling operations: control the product labelling mixups-Part of DHR (e)    Control number for traceability

Sec. 820.130 Device packaging

Subpart L - Handling, Storage, Distribution, and Installation

Establish and maintain procedures to ensure that Prevent mixups, damage, deterioration (Sec. 820.140 Handling) control of storage areas and stock rooms (Sec. 820.150 Storage) maintain the distribution records(Sec. 820.160 Distribution) Installation and inspection instructions(Sec. 820.170 Installation)

Subpart M - Records

Sec. 820.181 Device master record.

Sec. 820.184 Device history record.

Sec. 820.186 Quality system record.

Sec. 820.198 Complaint files.

Subpart O - Statistical Techniques

Sec. 820.250 Statistical techniques.

Establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics. ------------------------------------------ References: 21 CFR 820: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

 

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