Skip to main content

510(k) Summary or Statement

BayBiotech.NET
A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request.

As per FDA definition, these are the definition of Summary and Statements:

Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant.

510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has been submitted, requests for copies of it are legally supposed to be furnished by FDA through the FOI process within 30 days after determining that the device is substantially equivalent to another device. A complete information about the essential components of a Summary can be found on FDA’s website.

510(k) Statements: If a 510(k) submitter chooses instead to provide a 510(k) statement, it must be on a separate letterhead page, clearly identified as "510(k) Statement," and signed by the certifier.
Written requests by any individual for a copy of the 510(k) must be fulfilled by the statement certifier within 30 days of receipt of the request. Only patient identifiers, trade secrets, and confidential commercial information may be purged from the statement. Those submitting 510(k) applications are not permitted to charge requesters for compiling and disseminating these data.

To read more about the 510(k) filing visit DeviceLink.

Comments

Post a Comment

Popular posts from this blog

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying crit...
1 comment
Read more