FDA
General Description
- Medical device is defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act. It includes not only the end product but also accessories and components.
- Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act
A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- Recognized in the official National Formulary, or the United States Pharmaco poeia, or any supplement to them,
Applicable Products
The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.
Conformity Assessment Procedure
- Medical devices are classified according to risk which the device poses to the patient. According to kinds of product and class, According to the product and its classification, Conformity Assessment Procedure will be categorized into Registration, 510(Premarket Notification & Special Control) and PMA (Premarket Approval).
- FDA applies one of 3 class based on the necessary regulation to check safety and effectiveness.
- In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest- risk.
Classification
- Class I, Devices
- Class I means the class of devices that are subject to only the general controls.
- Product type: Bandage, surgical gloves, surgical knife, surgical brush.
- Class II, Devices
- Class II means the class of devices that is or eventually will be subject to special controls.
- Product type: Condoms, Contact lenses, Infusion pump, Bone powder, Dental material.
- Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the act.
How to register Medical device (510k)
- (Premarket Notification, 510(k)
- Applied to Class I, II medical devices
- Class I medical devices is 510 k exempt but some of class I medical devices and class II medical devices should submit premarket notification to FDA.
- 4. Lists of Premarket Notification include registration of facility.
- ① Audit Period: 90 days -180 days (Sometimes, It takes 1 year)
- ② Contents of Premarket Notification:
- Writing name of applicant, address of applicant, Manufacturer, address of sterilization facility, registration number and application date.
- Explanation of product: name of product, classification, appearance and structure, intended use, principle of operation, labeling and performance standard
- Substantial Equivalent data: Test report, Test report about performance and biocompatibility
Premarket Approval application: (PMA)
- Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
- Contents of Premarket Approval application
- Test method, test report, document of safety and effectiveness
- It is compulsory to apply general regulation of registration, badness etc. GMP audit is also compulsory. Audit of safety and effectiveness is added.
- 4 step audit
- ① Audit Period: 90 days -180 days (Sometimes, It takes 1 year)
- ② Contents of Premarket Notification:
- ③ Panel Review
- ④ Notification of final discussion and FDA approval
- Other requirements
- ① Preclinical laboratory testing data
- ② Animal testing data
- ③ Human clinical testing data
- ④ Good Manufacturing Practices
Medical devices requirements
- Registration of Manufacturing Establishment
- Listing of all Devices Manufacturing
- Record Keeping & Reporting by the Manufacturer
- Regulation of making labeling
- Regulation of refund and repair of medical device
- Registration of medical device and facility every year
Surveillance audit
- FDA audit approved medical device regularly for surveillance control. After FDA determination of audit, FDA performs audit according to GMP regulation.
