Preapproval Inspections for Manufacturing. Christy Foreman Deputy Director Division of Enforcement B Office of Compliance/CDRH

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1 Preapproval Inspections for Manufacturing Christy Foreman Deputy Director Division of Enforcement B Office of Compliance/CDRH

2 Major Steps Review of the Quality System information Inspection requests generated Inspections scheduled and completed Establishment Inspection Report (EIR) written EIR reviewed Office of Compliance District Offices Office of Compliance

3 Types of Submissions that could generate an inspection request: Original PMAs and PDPs Modules will be inspected after it has converted to a PMA Site Change supplements Certain HDEs Submissions for which a facility has a current OAI classification

4 When do we request an inspection? Originals: We will request an inspection for all sites in most cases Site Changes 2 year rule (inspection type, device type, processes inspected) Applies to existing facility and proposed facility

5 Preapproval Inspections An inspection assignment will not be issued until the applicant successfully addresses any Quality System deficiencies. FDA may cancel the inspection assignment under the following circumstances: if the PMA is not filed; ODE or OIVD issues a major deficiency, not approvable, denial, or withdrawal letter; or, the applicant communicates to FDA that the manufacturing site is not ready for inspection. Inspections are completed by the FDA District Offices

6 1/01 AL HI Office of Regulatory Affairs OR CA PACIFIC WA NV REGIONAL OFFICES - 5 DISTRICT OFFICES - 19 RESIDENT INSPECTION POSTS OCI FIELD OFFICES - 6 OCI RESIDENT OFFICES - 4 OCI DOMICILES - 4 ID AZ MT UT WY NM CO ND SD SOUTHWEST CENTRAL MN NE KS OK TX WI IL IA MO MI IN OH PA AR KY WV LA VA MS NORTHEAST NJ MD DE AL TN GA SC NH VT NY FL SOUTHEAST NC ME MA RI CT PR

7 7 Subsystems of the Quality System Design Control Material Control Corrective & Preventive Action Control Management Control Documents, Records & Change Control Production & Process Control Facility & Equipment Control

8 How long does it take? The inspection should be completed within: 45 days domestic (issued at day 32) 60 days foreign (issued at day 17) from the issuance of the assignment. The District then has an additional 30 days to complete the Establishment Inspection Report (EIR).

9 Preapproval Inspections Preapproval EIRs and any FDA 483s issued are sent to OC for a Quality System review and concurrence on the classification of the inspection. OC has 30 days to review this assignment.

10 Preapproval Inspections From the review of the EIR, if the inspection is classified NAI or VAI, this typically results in a recommendation of PMA approval with respect to manufacturing. If the inspection is classified OAI or there are outstanding 21 CFR 820 issues, then approval is not recommended until the issues are resolved and another inspection has been conducted and is classified NAI or VAI.

11 Important Things for a Preapproval Inspection Ensure your facility is ready. This includes the completion of process validation activities. Ensure that you have identified all facilities that are used in the manufacture of the device.

12 Preapproval Reinspection An applicant may be informed that a reinspection is necessary before approval of the premarket submission because of problems identified during the pre-approval inspection.

13 PMA Approval OC will recommend PMA approval when: The Quality System Information has been reviewed and determined to be acceptable All inspections have been completed All EIRs have been reviewed and are classified as wither VAI or NAI

14 Post Approval Inspections Post approval inspections are usually scheduled months after approval. This inspection will primarily focus on any changes that may have been made to the design, manufacturing process and/or the quality assurance systems relative to the device or its manufacturing process and to ensure that the firm is complying with the MDR regulations.

15 Relevant Guidance Guidance for Industry and FDA Staff The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations Compliance Program Medical Device Premarket Approval and Postmarket Inspections

16 Questions? Phone: