Nomenclature of medical devices

Nomenclature of medical devices

Medical devices are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these.

What is the nomenclature of medical devices?

To simply put it, the nomenclature is the naming of a medical device. Although medical devices are classified into different risk classes, they should be named so that it is universally identified. Standardised nomenclature facilitates this easy identification.

A nomenclature is needed to simplify trade and tracking among the different regulatory authorities, Ministries of Health, and other organisations that regulate medical devices.

A standardised nomenclature aids in the following aspects:

  • Grouping and classification of medical devices.
  • Registration under different regulatory bodies or Ministries of Health
  • Streamlined procurement and distribution
  • Grouping of medical devices in various electronic health records and medical device databases
  • Vigilance reporting, field safety and post-market surveillance
  • Unique Device Identifiers (UDI)

Medical Device Nomenclatures

The different device nomenclatures available are as follows:

  • GMDN or Global Medical Device Nomenclature.
  • EMDN or European Medical Device Nomenclature
  • UMDNS or Universal Medical Device Nomenclature System
  • Other nationally developed nomenclature systems

Global Medical Device Nomenclature (GMDN)

About 10% of countries use Global Medical Device Nomenclature worldwide. It is a system of internationally accepted descriptors used to identify medical devices. The GMDN Agency manages GMDN codes, a non-profit organisation.

GMDN is a 5-digit code containing the following information:

  • GMDN Term Name: Anaesthesia ventilator
  • GMDN Code: 34851
  • GMDN Definition: A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator but adequately meets the patient’s ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern. It is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.

Source: gmdnagency.org

GMDN was introduced for a variety of regulatory purposes. GMDN is based on the ISO 15225: Medical device nomenclature data structure’. Read more about the frequently asked questions about GMDN here.

European Medical Device Nomenclature (EMDN)

European Medical Device Nomenclature or EMDN is introduced due to Article 26 of EU Regulation 2017/745 of Medical devices and Article 23 of EU Regulation 2017/746  of in-vitro diagnostic medical devices. Like GMDN, it plays a considerable role in device nomenclature and serves various regulatory purposes. One of the primary uses is while registering a medical device in EUDAMED where it is closely linked to UDI-DI.

Structure of EMDN

The European Medical Device Nomenclature is characterised by its alphanumeric structure and is established in a seven-level hierarchical tree where it clusters medical devices into three primary levels:

Categories: the first hierarchical level – alphanumeric.

Groups: the second hierarchical level – 2 numbers indicating group.

Types: the third hierarchical level – a series of numbers 1,2,3,4 and 5.

EMDN was adopted from the Classificazione Nazionale Dispositivi medici (CND) classification. The EMDN can be accessed at the EMDN list. European Medical Device Nomenclature categorises into three primary levels, categories, groups, and types. A category comprises several groups composed of various kinds of medical devices.

Source: https://webgate.ec.europa.eu/dyna2/emdn/. In the above image of EMDN, ‘A’ is the category, ‘A01’ is Group and ‘A0101’ to ‘A0199’ are the types of medical devices.

Universal Medical Device Nomenclature System (UMDNS)

Universal Medical Device Nomenclature System or UMDNS was developed by the Emergency Care Research Institute (ECRI). Many nations have adopted this standard around the world. UMDNS is used in inventory control, work order control, and regulatory systems applications. It is a 5-digit code unique code and a term for different types of medical devices. One can find the UMDNS code list here. UMDNS is updated monthly.

CND Nomenclature

CND nomenclature or ‘Classificazione Nazionale Dispositivi medici’ was developed by Italian Ministry of Health. In addition to Italy, it is also used in Portugal and Greece. The guidance document on CND nomenclature explains the basic principles and structure of CND, which also applies to EMDN as EMDN was adopted from CND nomenclature. Following this, medical devices are clustered into three levels:

  • Category
  • Group
  • Type

FAQs

Is UDI the same as GMDN?

Both Unique Device Identification System (UDI) and GMDN are used in device identification. However, the two have some fundamental differences. UDI is inferior because of its lack of unity. It does not have a structure; therefore, device identification becomes more difficult with UDIs. Nonetheless, it is an effective tool for the traceability of medical devices. FDA utilises UDIs for medical device identification. The user guide to GUDID explains how the UDIs are managed in US FDA’s database, GUDID.

Can EMDN be accessed free of charge?

The EMDN is accessible to all stakeholders- free of charge. Hence, it can be utilised by a non-exhaustive list of stakeholders such as manufacturers, patients, research organisations, practitioners, hospitals, etc. The EMDN can also be downloaded from here.

Is there a guidance document that helps economic operators to map the EMDN information into the forthcoming EUDAMED database?

Yes, there are two guidance documents released by the EU commission
EMDN – the nomenclature of use in EUDAMED
The CND nomenclature – background and general principles


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Current Good Manufacturing Practices (cGMPs) of the FDA

Current Good Manufacturing Practices (cGMPs) of the FDA

The FDA introduced current Good Manufacturing practices (cGMP) to maintain a system that provides proper design, monitoring, and control of manufacturing processes and facilities. The cGMP standards ensure products’ identity, strength, quality, and purity by requiring manufacturers to maintain proper control over their manufacturing processes. This system helps the manufacturer avoid as many failures and errors as possible. The “C” in cGMP refers to “current,” which means that organisations must employ up-to-date technologies and systems to comply with the rules.

The cGMP is subdivided into the following chapters:

  • Subpart A-General Provisions (§§ 820.1 – 820.5)
  • Subpart B – Quality System Requirements (§§ 820.20 – 820.25)
  • Subpart C – Design Controls (§ 820.30)
  • Subpart D – Document Controls (§ 820.40)
  • Subpart E – Purchasing Controls (§ 820.50)
  • Subpart F – Identification and Traceability (§§ 820.60 – 820.65)
  • Subpart G – Production and Process Controls (§§ 820.70 – 820.75)
  • Subpart H – Acceptance Activities (§§ 820.80 – 820.86)
  • Subpart I – Nonconforming Product (§ 820.90)
  • Subpart J – Corrective and Preventive Action (§ 820.100)
  • Subpart K – Labelling and Packaging Control (§§ 820.120 – 820.130)
  • Subpart L – Handling, Storage, Distribution, and Installation (§§ 820.140 – 820.170)
  • Subpart M – Records (§§ 820.180 – 820.198)
  • Subpart N – Servicing (§ 820.200)
  • Subpart O – Statistical Techniques (§ 820.250)

Quality System Requirements

  • Establishing appropriate policies for maintaining quality requirements and ensuring they are followed in responsibility of the manufacturer. Handling matters such as the responsibility, authority, and interrelation of all personnel, resource allocation, quality plan, quality system procedure, and instructions is the manufacturer’s responsibility.
  • A representative must be appointed who ensures the quality requirements and periodically reports its performance to the executive management.
  • Quality audits must be mandatorily performed by personnel who are not directly responsible for the matters under audit and reports of such audits must be documented and shared with executive management. Ensuring availability of trained personnel for each task, and training activities for the same is must.

Design Controls

  • Every manufacturer, irrespective of any device class should maintain a specific design plan that must include design input requirements and the development process, which should be reviewed and updated periodically.
  • The manufacturer must maintain procedures to define and document design input and output data and be reviewed regularly. The results of design reviews must be documented in the design history file (DHF).
  •  The manufacturer is also expected to maintain procedures for verification and validation of the design procedure. Design changes and procedures for the changes to product specifications must be part of the manufacturer’s design control plan.

All information listed above must be part of the manufacturer’s Design History File (DHF).

Document Controls

This subpart describes how documents should be verified before distribution.

  • A responsible for checking document adequacy before circulation with their signature and date of verification is must and should be documented.
  • Any changes to the documents can be verified by an individual(s) in the same function or organisation unless specifically designated and changes made are to be communicated to the concerned person.
  • Information such as the description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective must be part of the change record.

Purchasing Controls

This subpart describes that each manufacturer must maintain a procedure to verify if all purchased or received products conform to the specified requirements.

  • Manufacturers must evaluate and document their suppliers, contractors, and consultants for all specified requirements, including quality requirements. The type of control over these operators must be defined, and a list of permissible operators should be documented.
  • It is a must to maintain data with a clear description or reference to specified requirements, including servicing. Purchasing data shall be approved in accordance with Sec 820.40.

Identification and Traceability

This subpart describes identification and traceability requirements.

  • Manufacturers must establish methods to identify the product during all stages of receipt, production, distribution, and installation to prevent mix-ups. Devices intended for surgical implants or to support or sustain life must have procedures to identify the product with a control number 0f each unit, lot or batch of finished devices. This will help while taking corrective action. Such identification details must be documented in DHR.

Production and Process Controls

This subpart describes how the manufacturer should develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications.

  • Details of Documented instructions, SOPs, methods that define and control the manner of production, monitoring and control of process parameters, compliance with specified standards, and approval processes criteria for workmanship must be included where process control is required.
  • Production and process changes must be verified and validated according to Sec 820.75, and changes shall be approved in accordance with Sec 820.40. There must be proper procedure to maintain its working if environmental control is applicable.
  • Details on personnel, contamination control, buildings, Equipment, Maintenance schedule, Inspection, Adjustment, Manufacturing material and automated processes are mentioned in detail in this section.

Section 820.72 describes inspection, measuring and test equipment. Various aspects from the control of inspection, measuring and testing equipment to its calibration and records are discussed in detail in this section.

Section 820.75 describes process validation. The processes must be verified with a high degree of assurance and approved according to established procedures.

Manufacturers must maintain procedures for monitoring and control of validated processes. Any changes or deviations in the process should be reviewed, evaluated, revalidated if necessary, and appropriately documented.

Acceptance Activities

This subpart describes the process of receiving in-process and finished device acceptance and acceptance status in detail. Finished products shall not be released for distribution until:

(1) The activities required in the DMR are completed
(2) the associated data and documentation are reviewed
(3) the release is authorised by the signature of a designated individual(s)

(4) the authorisation is dated.

The acceptance record shall include the following details:

(1) The acceptance activities performed
(2) the dates acceptance activities are performed
(3) the results
(4) the signature of the individual(s) conducting the acceptance
activities
(5) where appropriate, the equipment used. These records shall be part of
the DHR

To ensure that the product that has passed the required acceptance activities is distributed, used, or installed, the identification of acceptance status must be maintained throughout the product’s production, packaging, labelling, installation, and service.

Nonconforming Products

This subpart describes the control of nonconforming products and nonconformity review and disposition.

  • A procedure to identify, document, evaluate, segregate, and disposition a nonconforming product must be maintained by the manufacturer. The evaluation and investigation results must be documented.
  • The manufacturer must also establish and maintain a procedure for rework, such as retesting and re-evaluating nonconforming products after rework. All these activities must be documented in the DHR (Device History Record).

Corrective and Preventive Action

This subpart describes corrective and preventive actions. Procedures such as analysing, investigating, identifying, verifying, implementing, ensuring correct information, and submitting relevant information for all processes must be established and followed by the manufacturer.

All the nonconforming products must be reported and documented. During the verification process, the manufacturer must ensure that the corrective and preventive action should be effective and should not adversely affect the finished device.

Labelling and Packaging Control

This subpart describes how to establish and maintain procedures to control labelling activities.

  • Labels affixed to the device must remain legible throughout the manufacturing process and until it is delivered to the end-user.
  • Manufacturers must establish a procedure for labelling inspection, labelling storage, and labelling operations. During the inspection process, the responsible person must ensure the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions present on the label.
  • A control number as per Sec820.65 for each product must be part of the labelling. This subpart also mentions that the manufacturer must establish a proper procedure for device packaging during different stages of the manufacturing process.

Handling, Storage, Distribution, and Installation

This subpart describes the product’s handling, storage, distribution, and installation.

  • During storage and handling, the manufacturer must ensure that mix-ups, damage, deterioration, contamination or other adverse effects must not affect the product.
  • Manufacturers must establish a procedure to authorise the receipt and dispatch the product to storage rooms. Manufacturers must maintain distribution records which should include the following:

(1) The name and address of the initial consignee
(2) The identification and quantity of devices shipped
(3) The date shipped
(4) Any control number(s) used.

Further, Details on Installation procedures to be adopted by the manufacturer are given in detail.

Records

This subpart describes the requirements of record keeping.

  • The manufacturer is expected to maintain confidentiality if required and a set record retention period for all records as per the nature of the document.
  • It shall include device specifications, production process, Quality assurance procedures, packaging, labelling, installation, maintenance, and servicing procedures and methods.
  • The manufacturer must also maintain a Device history record (DHR) which should contain the following information:

(a) The dates of manufacture
(b) The quantity manufactured
(c) The quantity released for distribution
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR
(e) The primary identification label and labelling used for each
production unit
(f) Any unique device identifier (UDI) or universal product code (UPC),
and any other device identification(s) and control number(s) used

Detailed information on complaint files and Quality system records are also included in this subpart.

Servicing

This subpart describes servicing requirements.

  • Manufacturers are expected to analyse service reports with appropriate statistical methodology as per Sec 820.100.
  • Any service report that must be reported to the FDA under part 803 of the CGMP document shall automatically consider the report a complaint and proceed according to Sec 820.198. In general, the service report must include the following details:

(1) The name of the device serviced
(2) Any unique device identifier (UDI) or universal product code (UPC)
and any other device identification(s) and control number(s) used
(3) The date of service
(4) The individual(s) servicing the device
(5) The service performed
(6) The test and inspection data

The last subpart of the CGMP document gives details of Statistical Techniques to be used while following the CGMP guidelines.

FAQs

What are the field safety corrective actions of the FDA?

FDA has a stringent FSCA requirement. Refer to our article to understand the FDA’s field safety corrective action procedures.

Are there exemptions from GMP?

Medical devices published in the Federal Register and codified in 21 CFR 862 to 892 and exempted by FDA classification regulations are exempted from following the GMP requirements. However, manufacturers of finished devices must maintain complaint files (21 CFR 820.198) and general requirements concerning records (21 CFR 820.180). Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30 of the QS regulation.

Is it acceptable for a manufacturer to produce sterile products by aseptic processing to rely solely on ISO standards to qualify the facility?

No, in addition to the ISO standards it is required that the manufacturer follows applicable FDA regulations.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Summary of Safety and Clinical Performance (SSCP)

Summary of Safety and Clinical Performance (SSCP)

Summary of Safety and Clinical Performance (SSCP) acts as a vital document that allows the public to access information quickly. The information in the SSCP can be sourced entirely from the technical file. The technical file consists of the Post Market Surveillance (PMS), risk assessment, post-market clinical follow-up (PMCF) plans and reports. The SSCP document is required for high-risk devices only-this includes Class III and all implantable devices. Manufacturers of custom-made or investigational devices need not produce this document. Implant card together with SSCP enables an efficient system to access device information.

SSCP for medical devices under MDR

Under MDD, the information on medical devices was not easily attainable. Therefore, the end-users of most medical devices were deprived of information regarding even high-risk medical devices. As a result, medical devices under the directives lacked clarity. The main reason why SSCP is introduced is that MDR, unlike the directives, brings accessibility of information into account. The SSCP should be made available on the EUDAMED website for easy access. It should be assigned an identifier that remains the same throughout the document’s lifetime. This identifier is not subjected to changes even when the content of this document is revised.

Language and readability requirements

SSCP follows the MDR language requirements like the other technical documents, such as Instructions for Use. All intended users within the EU understand no single language. Therefore, language translations should be made available to intended users and patients. The SSCP should be translated into the languages accepted in the Member States where the device is intended to be sold.

Healthcare professionals widely understand English. Having an English translation available is essential, even if it is not available in selecting the official languages of each Member State. This enables the access to information that EU MDR strives to achieve.

While preparing SSCP, readability is an essential factor. The manufacturers must bear in mind to produce two sections. One part for intended users/healthcare professionals, and a second part for patients if applicable. It is recommended to use an appropriate method to confirm that the document is understandable to the member of both categories. Further guidance on the readability, translations and other factors involved in SSCP can be found in the MDCG guidance on Summary of safety and clinical performance.

Sections of Summary of Safety and Clinical Performance

Article 32 of the EU MDR states some sections that are a must. The manufacturer may add further information from the Technical Dossier/File if relevant to the users.

The following sections are mandatory in an SSCP for healthcare professionals:

  • Details of the device and manufacturer (including UDI details).
  • Intended use of the device.
  • Description of the device and its components. Previous variants of the device.
  • Indications, contraindications, and target demographic.
  • Details of residual risks, undesirable effects, warnings, and precautions

Risks, undesirable effects, and warnings should be mentioned in SSCP. Other relevant aspects of safety, serious events, and a summary of any field safety corrective action must be included if applicable.

  • A summary of the Clinical Evaluation of the device.

This section is intended to summarise the clinical evaluation results and the clinical data, the evaluation of undesirable side-effects, and the benefit-risk ratio’s acceptability.

It is an objective and balanced summary of the clinical evaluation results of all the available clinical data related to the device. It should comprise favourable, unfavourable, and inconclusive data.

  • Conclusions based on evidence and the safety and performance of the device.
  • Suggested profile and training for users
  • Applied harmonised standards

All commonly applied specifications and international standards harmonised and adopted monographs should be listed in SSCP.

  • Revision history

Revision history should contain details such as revision validated by Notified Body (NB) and the language of SSCP validated.

A patient-specific SSCP template follows the same high-level structure as the clinician SSCP but does not include the reference to harmonized standards and common specifications. This decision focused on the information most relevant to patient health.

Validation of SSCP

When the Notified Bodies (NB) have assessed that all the required elements are included in the draft SSCP with the most current version of relevant documents in the TD, the SSCP has been validated by the NB.
SSCP validation may depend on the class of device and the conformity assessment routes chosen. More guidance on validation by NB can be found in the MDCG guidance on SSCP.

Uploading SSCP to EUDAMED

SSCP should be made available online for the users who intend to read the document. It is uploaded in EUDAMED by the Notified Bodies, the only actor managing the SSCPs in EUDAMED. After each validation process, NB shall upload the updated SSCP by replacing the older version. However, once the ‘master’ SSCP is uploaded, it is up to the manufacturer to upload the translations to EUDAMED.

FAQs

What resources can be used for the SSCP?

The technical files like the design validation report, risk management report, clinical evaluation report (CER), as well as Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) reports. The Instructions for Use of the device can also be used as information for preparing the SSCP. Please note that SSCP cannot replace the IFU.

How frequently should SSCP be reviewed or updated?

The SSCP should be ideally updated annually. Documents like the PMCF evaluation and periodic safety update reports (PSUR) are updated annually. It is recommended to update SSCP along with the other technical documents.

How can I access the SSCP?

SSCP will be made available with the launch of the EUDAMED database. SSCP is accessible to both healthcare professionals and patients. SSCP has clear information for healthcare professionals with prior knowledge of medical terminologies. In addition to this, SSCP should also contain a section that patients of different levels of expertise easily understand.

When should a manufacturer of Class III medical devices prepare SSCP? 

SSCP should be made available at the time of registration.

Is there a similar requirement under IVDR?

Article 29 of In Vitro Diagnostics Regulation 2017/746 (EU IVDR) describes a requirement like the SSCP: the Summary of Safety and Performance (SSP). The SSP requirements are almost identical to those of the SSP, replacing ‘clinical’ for ‘performance’ evaluation. Also, it includes a requirement for metrological traceability of assigned values intended for analytes used in IVDs. For more information on IVDR, read our article on IVDR 2017/746.

Field Safety Corrective Action (FSCA) – US FDA

Field Safety Corrective Action (FSCA) – US FDA

What is Medical Device Reporting?

Medical Device Reporting (MDR) is one of the FDA’s post-market surveillance techniques for monitoring device performance, detecting potential device-related safety concerns, and contributing to device benefit-risk assessments.

  • There are mainly two groups of reporters of which the mandatory group includes the manufacturer, importers and device user facilities, and the voluntary group includes healthcare professionals, caregivers, patients, consumers
  • Once submitted, the FDA reviews the MDR and validates the totality of the given information
  • The MDR submission by itself cannot act as evidence that the device is responsible for a particular adverse event unless the reporter believes that the adverse event has or may have occurred due to the device or the device has a role in the mentioned event

What Event Qualifies to be Reported?

  • A device placed in the market contributes to a death or a serious injury
  • A device has malfunctioned and is likely to cause death or a serious injury if the malfunction were to recur

Who can Report an Adverse Event to FDA?

It is considered mandatory for the manufacturers, importers, and device user facilities) of reporters to report any adverse event through form FDA 3500A.

The summary of Requirements for Mandatory Reporting:

ReporterDescriptionFDA Form(s) Report toWhen to Report
Manufacturer30-day reports of deaths, serious injuries, and malfunctionsFDA 3500AFDAWithin 30 calendar days of becoming aware of an event
 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 healthFDA 3500AFDAWithin 5 workdays of becoming aware of an event
ImportersReports of deaths and serious injuriesFDA 3500AFDA and the manufacturerWithin 30 calendar days of becoming aware of an event
 Reports of malfunctionsFDA 3500AManufacturerWithin 30 calendar days of becoming aware of an event
User FacilityDevice-related DeathFDA 3500AFDA & ManufacturerWithin 10 workdays of becoming aware
 Device-related Serious injuryFDA 3500AManufacturer. FDA only if manufacturer unknownWithin 10 workdays of becoming aware
 Annual summary of death & serious injury reportsFDA 3419FDAJanuary 1 for the preceding year

(source-FDA Website)

The voluntary reporting can be done through MedWatch Online reporting Form or by requesting for assistance by calling 1-800-332-1088:

  • Healthcare professionals are advised to report through form FDA 3500
  • Patients/Consumers are advised to report through form FDA 3500B

In case of Emergencies, reporting can be done by contacting the FDA Office of Crisis Management, Emergency Operations Centre.

Who is Responsible to carry out Corrective Action for the Reported Event?

For any reportable or reported adverse events, the manufacturer is obliged to carry out a corrective action such that the implemented corrective action and preventive action aims to eliminate any device malfunctions related to patient safety. The manufacturers, importers and the user facilities are primarily responsible for carrying out a corrective action whose goal is to gather data, evaluate it, detect and investigate product and quality issues, and then take suitable and effective corrective action to keep them from happening again.

Medical Device Safety Action Plan Objectives

FDA carries out inspections to ensure that the corrective actions undertaken by the manufacturer are well adequate to eliminate any recurring adverse events.The Key objectives of such inspections are:

  • To create a medical device patient safety net in the United States of America
  • To put forward a system to check on the latest regulatory options to implement postmarket mitigations
  • To guide innovations to make a safer medical device
  • Bring Improvements in medical device cybersecurity
  • Integrate the premarket and post-market offices and operations of the Centre for Devices and Radiological Health (CDRH) to promote the implementation of a TPLC (Total product life cycle) approach to device safety

Corrective and Preventive Action (CAPA) Procedure

Every manufacturer is mandated to establish and maintain a CAPA process as per the FDA’s Quality System Regulation (QSR) 21 CFR 820.100. The process must well contain the requirements on input data sources, decision criteria of non-conformance, investigational procedure, root cause analysis, actions to address the non-conformance, effectiveness verification procedure, implement actions to eliminate recurring problems taking into consideration about the in-house product design changes as well as the impact to existing products in the market. The FDA requires all these activities to be documented and recorded.

  • Manufacturers are required to create a report as per 806.10 of any corrective actions implemented on the device and submit it to the FDA
  • Manufacturers and Importers must also keep records of the corrective actions that are not required to be reported to the FDA. Voluntary submission of such a report can be done based on 21 CFR 7

FDA’s Inspection Operation

On various grounds, the FDA performs inspections such as scheduled investigations, surveys, or a response to a reported problem. FDA’s Office of Regulatory Affairs (ORA) leads all such inspectional operations. There are FDA Forms involved in these inspections,

  • Form 482 “Notice of Inspection” presented by the FDA immediately prior to inspection
  • Form 483 is issued to the firm’s management at the conclusion of the inspection if the investigator determines observations that violate the FD&C act rules

Objectives of Inspection after implementation of a Corrective Action

  • Check if the corrective actions implemented have been well defined and documented
  • Verify if the right sources of product and quality issues have been found
  • Check if there are any unfavourable trends in the product and quality information
  • Verification of the received data based on completeness, accuracy and time of reception
  • Check if appropriate statistical methods are applied to detect and identify the extent of recurring quality problems
  • Verify if a failure investigation is carried out and check if there has been a genuine attempt to find the root cause (wherever possible)
  • Check if there is control for the prevention of distribution of non-conforming products
  • Verify if appropriate actions have been taken for significant product and quality problems identified from data sources
  • The effectiveness of the corrective action is validified and verified before implementation by ensuring that the corrective actions do not lead to any adverse effects on the finished device
  • Check if corrective actions for product and quality problems were implemented and documented
  • Verify if all non-conforming product and quality problems and corrective actions have been properly disseminated, including dissemination for management review

FAQ

What is the Voluntary Malfunction Summary Reporting Program?

It permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis.

The VMSR program lets the manufacturers submit separate summary reports for each unique combination of the device model, brand name, device model, and problem code(s). Every summary report is made available to the public in the MAUDE. It is mandatory to submit individual reports of death or serious injury events continue to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

How to report Medical Devices licenced as biological products?

CBER (Centre for Biologics Evaluation and Research) is designated the lead centre in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 – Medical Device Reporting.

Where to search for the medical device Reports?

The Manufacturer and User Facility Device Experience database contains mandatory reports filed by manufacturers and importers from August 1996 to the present, all mandatory user facility reports from 1991 to the present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

What are the data that are not required to be presented for routine review?

In accordance with Agency policy (CPG 7151.02), records regarding the results of internal quality audits, management reviews, third-party audits (including ISO audits), or supplier audits are not required to be presented.