FDA Certification

In the United States, Medical Electrical Equipment is defined in Section 201(h) of the FD&C Act, and Medical Electrical Equipment is including accessories and components associated with those.
Therefore, Medical Electrical Equipment that does not require permission or declaration in Korea can go through certain procedures in the U.S. because of the large scope of Medical Electrical Equipment stipulated in the Korean Pharmacist Act.

How do I get FDA certification?

Medical Electrical Equipment Registration Act 510(k)
1. Report pre-sale, 510(k)
2. Applying for Class I or II Medical Electrical Equipment
3. Class I Medical Electrical Equipment except 510(k), but some Class I Medical Electrical Equipment and Class II Medical Electrical Equipment must be reported to the FDA for pre-marketing.
4. The list of pre-marketing reports includes registration of facilities.
① Evaluation period: 90 to 180 days (sometimes one year)
② Contents of the premarket report:
Applicant name, applicant address, factory, sterile facility address, registration number and support date
③ Product Manual: Product Name, Classification, Structure and Appearance, Intention, Behavior, Labels, and Performance Standards
④ Equivalence data: Test reports, performance and biocompatibility reports

Premarket Approval (PMA)
1. Premarket Approval (PMA) is a process for the safety and effectiveness evaluation of Class III Medical Electrical Equipment through scientific and regulatory requirements.
2. Contents of premarket approval
Test Methods, Test Reports, Safety and Validity Documents
Applying the general rules of registration is mandatory. GMP screening is also required. A review of safety and effectiveness is added.
3. Four stages of screening
① Screening period: 90 days-180 days (sometimes 1 year)
② Contents of premarket report
③ Review of documents
④ Final Discussion Report and FDA Approval
4. Other Requirements
① Preclinical test data
② Animal test data
③ human clinical test data
④ Good drug manufacturing management standard

What products and product lines are eligible for FDA certification?

Applicable Products: Product codes are classified for Medical Electrical Device products according to 21CFR Part 862-892.

1. Class I Equipment
Class I is a general-purpose device.
Product types: Bandages, Surgical Gloves, Surgical Knives, Surgical Brushes
2. Class II Equipment
Class II is a device that ultimately requires special control.
Product Type: Condom, Contact Lens, Infusion Pump, Bone Powder, Dental Materials
3. Class III are devices requiring premarket approval in accordance with Section 515.

How do I follow up on FDA certification?

FDA reviews regularly approve Medical Electrical Equipment for surveillance and control. After the FDA review is determined, the review is conducted in accordance with GMP regulations.

Contact Person

Kim young bin