What is FDA 21 CFR PART 510(k) & Who Needs To Comply?
What is FDA 21 CFR PART 510(k)?
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
Who is Required to Submit a 510(k)?
The following four categories of medical device manufacturers must submit a 510(k) to the FDA:
(1) Domestic manufacturers introducing a device to the U.S. market
(2) Specification developers introducing a device to the U.S. market
(3) Repackers or relabelers who make labeling changes or whose operations significantly affect the device
(4) Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market
Who is NOT Required to Submit a 510(k)?
"Preamendment Devices" or "Grandfathered" devices legally marketed in the U.S. by a firm before May 28, 1976 do not require a 510(k) if they have not been:
* significantly changed or modified since then; and
* for which a regulation requiring a PMA application has not been published by FDA
The device must have the same intended use as that marketed before May 28, 1976. If the device is labeled for a different intended use, then the device is considered a new device and a 510(k) must be submitted to FDA for marketing clearance.
What are the sections required for a 510(k) submission?
Section 1.0 – Medical Device User Fee Cover Sheet (Form FDA 3601)
Section 2.0 – CDRH Premarket Review Submission Cover Sheet
Section 3.0 – 510(k) Cover Letter
Section 4.0 – Indications for Use Statement
Section 5.0 – 510(k) Summary
Section 6.0 – Truthful and Accuracy Statement
Section 7.0 – Class III Summary and Certification
Section 8.0 – Financial Certification or Disclosure Statement
Section 9.0 – Declarations of Conformity and Summary Reports
Section 10.0 – Executive Summary
Section 11.0 – Device Description
Section 12.0 – Substantial Equivalence Discussion
Section 13.0 – Proposed Labeling
Section 14.0 – Sterilization and Shelf Life
Section 15.0 – Biocompatibility
Section 16.0 – Software
Section 17.0 – Electromagnetic Compatibility and Electrical Safety
Section 18.0 Performance Testing – Bench
Section 19.0 Performance Testing – Animal
Section 20.0 Performance Testing – Clinical
How does LuitBiz help you become FDA 21 CFR PART 510(k) compliant?
Requirement
What it means
How LuitBiz helps
Complete Device Description/Performance Data
You should have a clear and comprehensive description of your device and its intended use
Medical Device companies can use the "Product Wiki" feature of LuitBiz DMS to store complete information about their devices including related documents, images, videos, manufacturing BOM, etc. Additionally, robust performance data to support your claims of substantial equivalence can be stored in LuitBiz DMS. This information is very crucial because sketchy details or missing data can raise red flags and delay the review process.
Clear Labeling or Instructions
Clear and accurate labeling is essential for safe and effective device use. You should have clear labeling and unambiguous labeling data that can be accessed during audits.
LuitBiz DMS allows you to store all data related to your labeling with the help of document tagging. This helps avoid ambiguous labeling, missing information, or instructions for use that are difficult to understand and can raise concerns about patient safety and potentially derail your submission.
Thorough Documentation and Testing Data
You need to have detailed documentation of your device’s design, development, and testing procedures that can be accessible during submission and audit
LuitBiz allows you to store detailed documentation of your device’s design, development, quality manuals, and testing procedures with version control and audit trail that can strengthen your submission. Additionally, all tests conducted on your device with reliable performance data can be stored in LuitBiz DMS as related documents that will bolster your claims of substantial equivalence.
Streamlined Workflow
You need to ensure that all document approvals are properly documented with electronic signature and available during submission
The workflow feature of LuitBiz DMS allows usersto set up workflows for document approvals. In LuitBiz DMS you can define workflows for certain folders and documents uploaded to those folders are required to follow those pre-assigned workflows ensuring proper documentation of approvals with electronic signatures.
Availability of Test Formats and Forms
Organizations should establish and maintain appropriate forms and templates to support the collection and recording of data. These forms may include customer complaint forms, non-conformity reports, audit checklists, training records, etc.
The "Document Library" feature of LuitBiz DMS allows users to share formats of test and data entry that can be downloaded by the users, and then uploaded into LuitBiz DMS after filling them up electronically or manually and then uploading the scanned copy to LuitBiz DMS. This helps in standardizing all test and quality forms that are used during submission and audits.
Alert Dates
You need to be aware of all the submission dates and timelines for FDA 21 CFR PART 510(k). Any delay might raise a red flag
LuitBiz DMS allows you to set alert dates for your documents that ensure that you are informed well ahead of time regarding you various submission dates. This way, you do not risk missing any deadline.
CAPA Management
You need to have complete details of the Corrective and Preventive Actions performed on your device during submission and audits
LuitBiz QMS allows you to have complete control of your CAPA forms and SOPs related to those CAPA forms. You can design your CAPA forms, attach them to SOPs, define workflows for their approval, get them approved and then implement your CAPA forms before sending them for closure. This ensures that your entire CAPA process is regulated.
Change Control & Distribution Of Controlled Copies
All Quality documents should undergo a change control process and only controlled copies of quality documents should be distributed for production
The "Document Control" feature of LuitBiz QMS streamlines the complete document preparation and change control process. It allows the quality manager to control the different versions of the documents and ensure distribution of controlled copies of documents only.