Traditional 510(k)s Review and Submission Services

Traditional 510(k)s Review and Submission Services
– Review and Submission Services are billed on an hourly basis.
– Estimated time from beginning to end will depend on your device’s compliance per the requirements.

Service Description:
– Traditional 510(k)s Review and Submission Services
– Device review per 201(h) of the FDA.
– Device review per 21 CFR 3.2(e).
– Facilitation with CDRH Product Jurisdiction Officer
– Facilitation with CBER Product Jurisdiction Officer
– Submission with the appropriate Center
– RFD# Identification Assistance
– RFD# Submission
– 21 USC 503(g)(5)©(ii)-(v) FDA Constituent Part of a Drug Review
– Device Type Review
– PMA – Premarket Authorization review and Facilitation with CDRH Office of Product Evaluation and Quality, Office of Regulatory Programs, or appropriate CBER Staff.
– Application of Integrity Policy -Clinical Studies Review.
– Organizational Element Preparation, Review, and Submission
– RTA – Request to Accept Facilitation
– Administrative Review
– Device Description Review
– Labeling Review per 21 CFR 801 and 809
– Sterilization Review
– Shelf-Life Review
– Software Review
– Cybersecurity Assessment
– Electrical Safety EMC Assessment
– Performance Data General Review
– Performance Characteristics

Requirements:
– Send applicable data, file, documents to services@consultareinc.com.
– Send approved company logo and your facility address to be incorporated on the documents, if applicable, to services@consultareinc.com.
– Review and Submission Services are billed on an hourly basis.
– Estimated time from beginning to end will depend on your compliance per the requirements.

Deliverables:
– 510(k) Review
– 510(k) Submission

Delivery Date:
– Assessment of the Project 3 Hours
– Review of requirements and standards 6 to 12 Hours
– Customization / Drafting / Initial gathering of information and document creation / Medical Device User Fee Cover Sheet (Form FDA 3601) 4 to 8 Hours
– CDRH Premarket Review Submission Cover Sheet 9 to 18 Hours
– Table of Contents 9 to 18 Hours
– Acceptance Checklist 15 to 30 Hours
– Statement of Indications for Use 9 to 18 Hours
– 510(k) Summary or Statement 9 to 18 Hours
– Truthful and Accurate Statement 9 to 18 Hours
– Proposed Labeling 60 to 120 Hours
– Specifications 30 to 60 Hours
– Substantial Equivalence Comparison 15 to 30 Hours
– Biocompatibility Testing of Medical Devices 180 to 360 Hours
– Performance 90 to 180 Hours
– Panel Review 15 to 30 Hours
– Revisions 30 to 60 Hours