How to Get The FDA Clearance?

In order to get FDA clearance for you product, you need to comply with one or more of the following requirements:

1. Establish and maintain a Medical Quality Management System, which complies with the GMP/QSR requirements

2. Construct and submit a product clearance application file (510(k) or a PMA) file

3. Contract a Regulatory Designated Agent in the USA

4. Register your company with the FDA

5. List your products with the FDA files

The actual requirements your product will need to comply with are subjected to the classification of your devices. This classification is based on the risk level established in Title 21 of the Code of Federal Regulations (CFR) – FDA, Parts 862-892.

Here are some examples of medical devices and there correlation to product classification classifications:

1. Class I: Corrective glasses, Crowns, EEG and EMG Electrodes non-invasive, Examination gloves, Hospital beds, Infusion cannula, Nebulizers, Needles for syringes, Scalpels, Stethoscopes for diagnosis, Stomach pumping tubes, Wheelchairs…

2. Class II: Anesthesia machines, Bioactive implantable devices, Blood oxygen analyzers, Bone cements with antibiotic, Brachytherapy devices, Condoms, Contact lenses, Electrodes, neurocortical, Extracorporeal Circulation Devices, Hemodyalizers, Incubators for babies, Infusion pumps, Lithotriptors, Lung ventilators, Muscle stimulators, Sterilizers for medical devices, Stretchers, Sutures absorbable, Syringes without needles, Ultrasound diagnostic equipment…

3. Class III: Catheters angioplasty balloon, Catheters with radioisotopes, Collagen implants, Contraceptive intrauterine devices (IUDs), Defibrillators external, Lenses intra-ocular, Prosthetic heart valves, Shunts carotid artery, Vascular stents

Example of compliance routes: Class I

1. Contract with a US Regulatory Designated Agent in the USA

2. Register the manufacturer through the Regulatory Designated Agent with the FDA

3. List the products through the Regulatory Designated Agent with the FDA.

Class II

1. 510k submission

2. Contract with a US Regulatory Designated Agent in the USA

3. Register the manufacturer through the Regulatory Designated Agent with the FDA

4. List the products through the Regulatory Designated Agent with the FDA.

5. Compliance with the cGMP/QSR requirements, as described in 21 CFR Part 820.

Class III

1. PMA submission

2. Contract with a US Regulatory Designated Agent in the USA

3. Register the manufacturer through the Regulatory Designated Agent with the FDA

4. List the products through the Regulatory Designated Agent with the FDA.

5. Compliance with the cGMP/QSR requirements, as described in 21 CFR Part 820.

How we can help: MedTech Guys will assist in preparing the 510k to obtain your FDA clearance. We can parallel process the implementation of a quality management system in compliance with the cGMP/QSR requirements. For instance the following steps will be taken for a 510k submission:

1. Preliminary research on device (i.e. classification, product code, guidance documents, standards)

2. Predicate device(s) assessment

3. Indications for Use Statement

4. 510k Compilation

5. Internal Review

6. Formal Review of 510k with Client

7. Submission to FDA

More info: You can find more information on this page: http://www.fda.gov/MedicalDevices/default.htm