In late July 2011, The FDA published a draft document of “510 (k) Device Modifications: Deciding When to Submit a 510 (k) for a Change to an Existing Device”. This draft updates FDA’s current position on when a modification to an existing medical device would trigger the requirement to submit a new 510(k) premarket notification.. When final, this guidance will supersede the 1997 “Deciding When to Submit a 510 (k) for a Change to an Existing 510(k)” guidance.The guidance has been updated to address issues associated with software and other rapidly changing technologies, and to provide greater clarity about changes that do not trigger the need for a new premarket submission.The types of modifications addressed include manufacturing process changes, labeling changes, technology or performance specification changes, and material changes.
This guideline describes approaches to developing process and drug substance 66 understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles 68 and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance. A company can choose to follow different approaches in developing a drug substance.
For the purpose of this guideline, the terms “traditional” and “enhanced” are used to differentiate two possible approaches. In a traditional approach, set points and operating ranges for process parameters are defined and the drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria. In an enhanced approach, risk management and more extensive scientific knowledge are used to select process parameters and unit operations that impact critical quality attributes (CQAs) for evaluation in further studies to establish any design space(s) and control strategies applicable over the lifecycle of the drug substance. As discussed in ICH Q8 for drug product, a greater understanding of the drug substance and its manufacturing process can create the basis for more flexible regulatory approaches. The degree of regulatory flexibility is generally predicated on the level of relevant scientific knowledge provided in the application for marketing authorization. Traditional and enhanced approaches are not mutually exclusive. A company can use either a traditional approach or an enhanced approach to drug substance development, or a combination of both.
“The source of TBA-contaminated drug products appears to have been 2,4,6-tribromophenol (TBP), a chemical used as a wood preservative. Certain fungi are able to survive in TBP-treated wood by converting TBP to its anisole analog, TBA. In the recent contamination incident, an investigation found that TBP-treated wood was used to manufacture pallets that were then used to ship and store drug packaging material. Currently, the use of halogenated phenolic compounds to preserve wood appears to be very rare as this practice is either discouraged or prohibited in many regions of the world, including the US. However, TBP treatment of wood continues in some regions that supply wood to the US and other countries.”
Read more here:
Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Buildings and FacilitiesQuestions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Buildings and Facilities
Medical Device Quality Management System – Class I or II Medical Device (electrical), US Distribution, without Software
Set of 6 checklists with 1 hour of telephone or email support: $595.00 or $195.00 per checklist. For additional information, please call 415.388.1695 or email.
Checklist 1: 21 CFR 820 The Quality System Regulation and 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes
Checklist 2: Quality System Inspection Technique (QSIT) – US FDA Field Investigator inspection technique
Checklist 3: 21 CFR 803 and 806 – Medical Device Reporting / Recall
Checklist 4: ISO 14971:2009 Medical devices – Application of risk management to medical devices
Checklist 5: 21 CFR 820.30 Design control + EN 60601-1 Third Edition
Checklist 6: 510(k) Traditional or Abbreviated Readiness