Overview
The US FDA requires a formal review / document of all changes to determine if new issues of safety and efficacy have arisen resulting in the need to file a new 510(k).
This webinar will discuss the FDA's draft guidance recommendations for PCCPs as part of 510(k) or PMA submissions where future device changes are basically known. It recommends. that a PCCP describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of their impact. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device, without necessitating additional marketing submissions for implementing each modification described in the PCCP. By including a PCCP in a marketing submission for a device, manufacturers can prospectively specify and seek premarket clearance / approval for intended future modifications to a device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such modifications – provided the changes are consistent with the PCCP that has been submitted and FDA-reviewed / cleared / approved.
Why Should You Attend
The US FDA is proposing a new addition to 510(k)s and PMA submissions: Predetermined Change Control Plans (PCCPs) for devices requiring premarket approval (PMA) or premarket notification (510(k)). A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed.
A recently published draft guidance, “Predetermined Change Control Plans for Medical Devices”, Draft Guidance for Industry and FDA Staff, for comment only, issued on August 22, 2024. It provides FDA’s current thinking on the information to include in a PCCP. It is also soliciting comments from stakeholders as to the proposals it discusses.
Webinar Takeaway
- FDA PCCP Proposed Expectations
- Key requirements of the Draft Guidance
- Expected sources of information for evaluation and inclusion
- How to complete, document and control PCCP elements.
- Components, Establish, ID a PCCP in a Submission
- Acceptable Modifications that are Included in the PCCP
- Content and Descriptions of Modifications
Who Will Benefit
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / PMA subnussuibs swhere future changes are anticipated. It is a dreaft, soliciting comments from stakeholders prior to finalization. But it does provide a glimpse of the FDA's current thinking on PCCP, subject to the solicited stakeholder inputs. This applies to companies in the Medical Device and combination products fields. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- R&D and Engineering
- All personnel tasked with new and changed product development and documentation
Faculty John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
