For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark.
The first day of this 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. The contents and rational for submitting a traditional, abbreviated and special 510(k) for a Class II Medical Device will be detailed. Labeling, Substantial Equivalence and Performance Testing for various medical devices will be detailed. In addition, the Refuse To Accept Checklist will be reviewed to help participants audit their 510(k) submissions for compliance to the checklist.
On day 2 of this course we switch gears to the EU and the requirements for the preparation of a Technical File. As an introduction, CE versus CE with a number, ISO 13485 or ISO 9001 Compliance versus Certification for a Class I device and what Annex to follow for the CE Mark will be explained. The contents of the Technical File will be detailed with examples of Essential Requirements Checklist, Clinical Evaluation Reports and Declaration s for Conformity will be presented. In addition, the key changes in the new Medical Device Directive will be reviewed.
Learning Objectives:
Upon completing this course participants will understand:
- 510(k) Notifications:
- Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
- When to file for a new device, a change in the intended use or a change in the technology of a cleared device
- What is contained in a traditional, abbreviated and special 510(k) submission package
- What is substantial equivalence and what’s required to show substantial equivalence
- What’s required on the labeling and IFU
- Which performance tests should be conducted and how to present the data to the FDA
- Understand the FDA’s Refuse to Accept Policy
- What is required in a submission for software controlled devices
- Technical File:
- Formatting a Technical File
- Determine Device Classification and Conformity Assessment Procedure
- Essential Requirements Checklist Requirements
- Clinical Evaluation Report Requirements
- Risk Management Plan and Reports Requirements
- Contents of a Declaration of Conformity
- Key changes in the new Medical Device Directive
Who will Benefit:
This course is designed for individuals who are tasked with preparing a 510(k) Notification or Technical File for a Medical Device. The following personnel will benefit from the course:
- Company CEOs and Presidents
- Regulatory Affairs Managers
- Quality Assurance Managers
- Regulatory and Quality Assurance Professionals
- Design Engineers
- Quality Engineers
- Legal Professionals
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- The 510(k) regulation
- Types of 510(k) submissions
- Preparation of a Traditional 510(k)
- Substantial equivalence
- Labeling requirements
- Performance testing
- Substantial equivalence
- Risk management documentation
- When are clinical trials required
- When and what’s required for a Special 510(k)
- When and what’s required for an Abbreviated 510(k)
- Guidance documents and FDA recognized standards
- FDA’s refuse to accept policy
- Review of the Medical Device Directive (MDD)
- Technical File contents per the MDD
- Determining product classification and rationale
- Conformity Assessment Procedure
- Essential Requirements Checklist Review
- Risk Management Plan and Report Requirements
- Product Information Requirements
- Clinical Data Review Options
- Labeling
- Examples of various Declaration of Conformities
James Barley
Regulatory Affairs and Quality Assurance Consultant
James Barley is a founder of Abrimed Consulting Services, a Medical Device Regulatory Affairs and Quality Assurance Consulting company. Mr. Barley graduated from Lowell Technological Institute with a degree in Engineering and later earned his Masters of Business Administration from Pepperdine University. During the last 20 plus years, Mr. Barley has been consulting for small and medium sized medical device companies. These services included setting up quality systems compliant with the FDA’s Quality System Regulation, ISO 9001 and ISO 13485.
In addition, Mr. Barley has prepared 510(k) submissions for instruments, disposables, electronic equipment and software as well as Technical Files for Class Im, 1s, IIa and IIb. Since the FDA has begun enforcing its Refuse To Accept Policy, Mr. Barley has successfully navigated through the requirements of the FDA Policy.
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