In Vitro Diagnostics (IVDs) are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act. According to section 351 of Public Health Services act, IVDs are biological products. Similar to any other medical devices, IVDs are also subjected to premarket or postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.
Some examples of IVDs are:[1]
- Hepatitis or HIV tests
- Clinical chemistry
- Coagulation test systems
- Urine test strips
- Pregnancy tests
- Blood sugar monitoring systems for diabetics
- Receptacles manufactured specifically for medical specimens
Classification Of IVDs By FDA
FDA has classified the IVDs into three classes, Class I, Class II, Class III. The classification has been based on the level of regulatory control that is necessary to reasonably assure the safety and effectiveness of the devices.
The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866.
|
CLASSIFICATION |
LEVEL OF RISK |
|
CLASS I |
NO PUBLIC HEALTH RISK OR LESS PERSONAL HEALTH RISK |
|
CLASS II |
LOW PUBLIC HEALTH RISK OR MODERATE PERSONAL RISK |
|
CLASS III |
MODERATE PUBLIC HEALTH RISK OT HIGH PERSONAL RISK |
|
CLASS IV |
HIGH PUBLIC HEALTH RISK |
IVDs & Covid-19
In terms of immediacy and global demand, SARS-CoV-2 presents a totally different opportunity and challenge compared to all other IVDs tests. The number of SARS-CoV-2 tests already being carried out worldwide most likely outstrips all other infectious disease testing.[2]
But, there are some IVDs that seriously exist and help in further diagnosis of corona virus infection.
The IVDs and SARS CoV-2 & COVID-19 have several enlisted:
- DIAGNOSTIC TESTS: Tests that detect the designated corona virus and the infection with SARS Cov-2 virus. These include molecular tests and molecular tests and antigens tests.
- SEOLOGY/ ANTIBODY AND OTHER ADAPTIVE IMMUNE RESPONSE TEST
These are the tests that detect anti bodies in the body of a person. These anti bodies are IgM, IgG. But the limitation of these tests are that these cannot be used when the person is currently infected.
- TEST FOR MANAGEMENT OF COVID-19 PATIENTS
There are some tests that are authorized for the use in the management of the patients with COVID-19 infection. These are basically bio markers to test the inflammation in the body.
IVDs though are useful, but they do possess risks when used without knowledge. They are:
- There is a risk of false positive and false negative results with all in-vitro diagnostic tests.
- Failure to follow the IFU may affect test performance and impact the validity of the test result.
- Positive results need to be considered alongside other clinical information such as past medical history, results from diagnostic testing and history of exposure.
- A false negative result may occur due to inadequate sample collection, storage, and/or handling, therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
- When self-swabbing is required, it can be difficult to ensure that a sufficient sample has been obtained. It is important to follow the instructions for use carefully.
- Some tests may not have been evaluated for use in asymptomatic individuals (i.e. individuals without signs and symptoms of respiratory infection). The test performance may differ in these individuals.
- The IFU may specify that the test must be used within a number of days post onset of symptoms.
- The predictive value of the test (probability of a given result being a true result) depends on the prevalence of the disease.
Approval needed in case of IVDs
Step 1
Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. The regulatory framework for medical devices is based on the Medical Device Rules, 2017. In India, only few Medical Devices and IVDs need approval and go through a lengthy approval system. A full list can be found in the CDSCO’s Notice on the classification of medical devices and IVDs. This is not an exhaustive list. CDSCO does not maintain a single list of regulated devices, but rather subjects devices to regulation through the Drugs and Cosmetics Rules, the Medical Device Rules 2017, and subsequent Gazette Notifications, which should be reviewed prior to making a final determination of a device’s regulatory status.
Step 2
The person manufacturing the IVD or medical device has to appoint an Authorized agent to interact with CDSCO on his behalf. The agent should comply with all the requirements.
Step 3
Class B, C, and D IVDs require in-country performance testing through the National Institute of Biologicals (NIB) or an accredited lab. Class D IVDs require performance testing through the National Institute of Biologicals (NIB). Class B and C IVDs require performance testing through an accredited Indian lab, though CDSCO may instead accept existing reports for such products with approval in a major regulatory market.
Step 4
The next step includes, compiling the applications, including manufacturing facility information, device technical information, ISO 13485 certificate, IFU, testing results (if applicable), clinical data (if applicable), proof of approval in the US, EU, Australia, Canada, or Japan, plus proof of approval in home country (satisfied by CFS/CFG).
Step 5
Then, we can file an application for registration/Import license with CDSCO and pay the required fees. The documents should be English.
Step 6
The CDSCO reviews applications and may require a Technical Presentation. Approximately 25% of applications require a formal Technical Presentation. The Technical Presentation is an in-person meeting with the CDSCO to discuss the product in more detail. A representative from the manufacturer (such as an engineer) is expected to attend this meeting along with the India Authorized Agent.
Novel devices will also undergo a Subject Expert Committee (SEC) review. Devices novel to the Indian market (new technology, material, intended use) may face additional regulatory hurdles. CDSCO may require clinical studies conducted in India prior to regulatory approval, or the agency may issue a restricted approval. A restricted approval could include a requirement to actively collect and submit post-market data. The SEC meeting will include local clinicians and other experts who will weigh in on the acceptability of the existing clinical data.
Step 7
The CDSCO issues an Import License in Form MD-15. Following the implementation of the Medical Device Rules, 2017, the processes for obtaining device registration and import licensing were combined in India. Accordingly, the CDSCO does not issue Registration Certificates under the Medical Device Rules, instead issuing market authorization for foreign devices through the Import License (Form MD-15).
The License does not expire; however, license retention fees are due every five years.
Step 8
Once approved, only the Indian Authorized Agent may import products. However, one can obtain multiple registrations for the same device through different Authorized Agents.
This is an improved outline of the process for approval. The CDSCO may choose to audit the submission and request more documents, which will add time to the IVDs approval.
Author: Apoorva, ICFAI Law School, ICFAI University, Dehradun
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[1] https://www.tuvsud.com/en-in/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/invitro-diagnostic-medical-devices-directive
[2] “In Vitro diagnostics and the corona virus pandemic”- Liz Thorn
