2018-12-14
a medical device entering the us market for commercial sale must be registered with the fda and must submit a pre-market notice at least 90 days ago. it is commonly referred to as the "510 (k) procedure" in the industry. at present, most of the first and second class products can be approved by fda after completing enterprise registration, product listing and gmp quality system and 510 (k) application.
the u.s. food and drug administration (fda) is currently seeking to modernize its 510 (k) regulatory review process in the hope that the public will pay more attention to medical devices that have been on the market for less than 10 years.
to achieve this goal, on april 12, 2018, the fda released a draft on extended and simplified 510 (k) procedures: substantially equivalent proof through performance standards, which is scheduled to be finalized in early 2019; safety networking (nest) in fiscal year 2019; and new regulations updating the "de novo" procedures in the next few weeks. the purpose of all the measures is to use the improved 510 (k) procedure as the main application way for listing of most products, so as to improve the intervention ability of fda and ensure the safety and effectiveness of the equipment in use with the emergence of safety problems.
in line with the improvement of 510 (k) procedures, the fda promotes the use of real evidence in regulatory decision-making through innovative safety nets and introduces new regulatory measures from scratch. it is reported that the national health technology assessment system (nest), a safety network funded by fda and industry, will be put into operation in the financial year 2019. cdrh also intends to issue a new regulation to update the "de novo" program in the next few weeks. the purpose of the update is to accommodate the expected increase in the use of 510 (k) s by manufacturers, which is based on the growing number of approval requests for most equipment. they also sought to provide consistency by compiling the review process and identifying the necessary elements to be included in the requirements.
