For Class II products with 60% market share in the United States, FDA has been applied to anesthesia, cardiovascular, clinical chemistry, dentistry, otolaryngology, gastroenterology, plastic surgery, routine equipment, hematology, immunology and microbiology.

In biology, neurology, obstetrics, ophthalmology, pathology, physiotherapy, radiology and toxicology, etc. 15 products, some products are selected (class I and class II need to complete the declaration of 5 10(K) before entering the United States.

Market, non-implantable, life-supporting or life-sustaining devices, products that do not need human clinical research) were authorized to 1 1 institutions (see Table 2) for third-party audit, thus speeding up the completion of such products in the United States.

Progress in market access. (Of course, for medical devices that can pass the third-party audit, manufacturers can still apply for market access audit directly to the FDA, not necessarily through a third-party organization. )

bsi

TUV SUD Americas Inc

Center for industrial measurement standards

Underwriters Laboratory Company.

CITECH

CHEIROON BV

Tianxiang test service

KEMA quality co., ltd

NIOM-Scandinavian Institute of Dental Materials

Supervision technical service co., ltd

TUV Rheinland Company of North America

Table 2 List of third-party audit institutions authorized by FDA

1. Qualifications for becoming a third-party audit institution authorized by FDA.

American Food, Drug and Cosmetic Act FD&; Article 704 of Bill C stipulates the basic requirements for becoming a third-party audit institution authorized by FDA:

(1) It must be a legal entity, but it cannot be subordinate to the federal government. It must be an independent organization that is not controlled by manufacturers, suppliers or sellers, has no organizational, practical and financial interests with manufacturers, suppliers and sellers, and does not engage in the design, assembly, sales or maintenance of medical devices.

(2) There must be enough staff with audit and inspection experience, skills and necessary training and education. The FDA requires the staff of third-party audit institutions to be familiar with the US Food, Drug and Cosmetic Act.

(FD & ampc Act), Public Health Service Act and related regulations 2 1CFR.

(3) The 3)FDA will adopt TPRB (Third Party Accreditation Committee) plan to evaluate whether the reporting institution has the ability of third-party audit.

2.FDA authorizes third-party audit institutions to review market access procedures:

After a preliminary review of the market access documents submitted by the manufacturers, the third party agency will forward the review opinions, suggestions and document 5 10(K) to the FDA. According to the requirements of laws and regulations, FDA must make a credible decision whether to issue market access license within 30 days. The difference between choosing a third-party auditing agency authorized by FDA and choosing to submit the market access audit directly to FDA is as follows:

figure

project name

Select the third-party audit institution authorized by FDA.

Submitted directly to FDA

1

FDA user fees

(FY 2007)

Generally, it is 2-3 times the FDA's usage fee.

4 180 USD

2

Review time of market access documents

Generally, a third-party organization will complete the document review within 30 days. After the review comments are fed back to the FDA, if the FDA does not require supplementary questions, it will issue a market access permit within 30 days (generally 15 days).

90 days

three

Response time for supplementary questions (if any)

The third party will take the form of timely communication.

30 days

four

After the supplementary question is answered, the time for FDA to issue the market access permission letter.

30 days (generally 15 days)

The rule is 90 days (usually 60 days).

3.FDA's supervision of third-party audit institutions

The Complaint Supervision Office (OC) under the Center for Device and Radiological Hygiene (CDRH) of FDA will supervise the third-party audit institutions authorized by FDA according to law.

The FDA will review the audit items completed by the third-party audit institutions, and regularly inspect the third-party audit institutions to ensure that they carry out relevant audit work in accordance with the requirements of laws and regulations, and record the process. When there is enough

The evidence shows that there is an interest relationship between the third-party audit institution and the applicant, and the FDA will follow the FD&; The requirements of Article 704 of act 704 initiated the procedure of revoking the qualification of the third-party audit institution.

Article 704 of FD & ampACT stipulates that when a third-party audit institution fails to perform the procedures according to the requirements of standards and regulations, it poses a threat to public health or has an interest relationship with equipment manufacturers and other institutions.

At that time, the FDA will revoke the qualification of the third-party audit institution. So far, FDA has not made a decision to revoke the qualification of authorized third-party audit institutions.

I hope it works for you. For more information about FDA registration and classification, please visit the official website of Suzhou Frida.