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Feb 08, 2023 •18 likes •368 views

Because the FDA Said So Convincing the Non-Believer You are going to impact the timeline w/ this last minute requirement. Everything doesnt need to be Is this really necessary? in a procedure. Why do we have to do this? What do you

  1. Because the FDA Said So Convincing the Non-Believer

  2. You are going to impact the timeline w/ this last minute requirement. Everything doesn’t need to be Is this really necessary? in a procedure. Why do we have to do this? What do you hear?

  3. • What are the common challenges? • Where do I go to prove what is required? • Walk thru examples Agenda

  4. • Documentation – defining what is required • Qualifications – validating it vs. verification • Records – recording what was done; i.e., the evidence Common Challenges

  5. Documentation / Procedures

  6. Qualification

  7. Records

  8. • FDA • EU – Preamble to the CFR – ISO Standards – Recognized Harmonized – NB-MED Standards – Guidance Documents – QUSIT / MDSAP – 483s – Warning Letters Guidance on Requirements

  9. • Procedures referenced in the QSIT guide: – Change Control – High-level Quality System – CAPA – Management Review – Failure Investigation – Quality Audit – Corrective & Preventative Action – Production – CAPA Inputs – Designated Management – MDR Procedures Representative – Medical Device Tracking – Purchasing Controls – Control, Monitoring, & Produce – Design Control Acceptance – Design Input – Process Validation – Design Output – Sterilization Process Controls – Design Review Procedures: QUSIT Guide

  10. • Preamble to CFR 820 Qualification

  11. Qualification

  12. • http://www.team-nb.org/nb-med-documents/ Notified Body Guidance Documents

  13. Notified Body Guidance Documents

  14. • Industry / Societies • Businesses – ANSI / ASTM – Emergo Group – GHTF / IMDRF – Quality Council of Indiana – AAMI – ISTA – ASQ • Network! – USP – Talk to people & ask – Attend meetings Guidance on Requirements

  15. Industry / Society Guidance

  16. Industry / Society Guidance

  17. Examples Thought process to convince the non-believer.

  18. • Step 1: Pull the regulations; ISO13485 & 21 CFR Part 820 • Step 2: Pull the QSIT Guide • Step 3: Pull recent 483s &/or Warning Letters Everything doesn’t need to be in a procedure. Design Control

  19. • ISO13485 • 21 CFR Part 820 – 7.3.1 The organization shall – Section 820.30 (a) General. (1) Each document procedures for design and manufacturer of any class III or class II development. device, and the class I devices listed in – 7.3.8 The organization shall paragraph (a)(2) of this section, shall establish and maintain procedures to document procedures for transfer of control the design of the device in order to design and development outputs to ensure that specified design requirements manufacturing. These procedures are met. shall ensure that design and – (c) Design input. Each manufacturer shall development outputs are verified as establish and maintain procedures to suitable for manufacturing before ensure that the design requirements becoming final production relating to a device are appropriate and specifications and that production address the intended use of the device, capability can meet product including the needs of the user and patient. The procedures shall include a requirements. mechanism for addressing incomplete, – 7.3.9 The organization shall ambiguous, or conflicting requirements. document procedures to control design and development changes. Step 1

  20. • 21 CFR Part 820 (f) Design verification. Each manufacturer shall – establish and maintain procedures for verifying (d) Design output. Each manufacturer shall – the device design. Design verification shall establish and maintain procedures for defining confirm that the design output meets the and documenting design output in terms that design input requirements. allow an adequate evaluation of conformance (g) Design validation. Each manufacturer shall to design input requirements. Design output – establish and maintain procedures for procedures shall contain or make reference to validating the device design. acceptance criteria and shall ensure that those design outputs that are essential for the proper (h) Design transfer. Each manufacturer shall – functioning of the device are identified. establish and maintain procedures to ensure that the device design is correctly translated (e) Design review. Each manufacturer shall – into production specifications. establish and maintain procedures to ensure that formal documented reviews of the design (i) Design changes. Each manufacturer shall – results are planned and conducted at establish and maintain procedures for the appropriate stages of the device's design identification, documentation, validation or development. The procedures shall ensure that where appropriate verification, review, and participants at each design review include approval of design changes before their representatives of all functions concerned with implementation. the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. Step 1

  21. • QSIT Step 2

  22. Step 3 – Recent Warning Letter

  23. Step 3 – Recent Warning Letter (cont.)

  24. • Step 1: Pull the regulations; ISO13485 & 21 CFR Part 820 • Step 2: Pull guidance documents • Step 3: Pull recent 483s &/or Warning Letters Is this really necessary? Validation

  25. Step 1 – 21 CFR Part 820

  26. Step 1 – ISO 13485

  27. Step 2 – Guidance Document

  28. Step 2 – Guidance Documents

  29. Step 3 – Recent Warning Letter

  30. • Step 1: Pull the regulations; ISO13485 & 21 CFR Part 820 • Step 2: Pull recent 483s &/or Warning Letters Why do we have to do this? Records

  31. Step 1 – 21 CFR Part 820

  32. Step 1 – 21 CFR Part 820

  33. • 8.3.4 Rework • The organization shall perform rework in accordance with documented procedures that takes into account the potential adverse effect of the rework on the product. These procedures shall undergo the same review and approval as the original procedure. • After the completion of rework, product shall be verified to ensure that it meets applicable acceptance criteria and regulatory requirements. • Records of rework shall be maintained (see 4.2.5). Step 2 – ISO13485

  34. Step 3 – Recent 483

  35. Tiffany Abrams tiffany_abrams@edwards.com Thank-you!

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