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Origami for FDA ISO13485 Transition

FDA CGMP to ISO13485

As a medical device manufacturer of a finished good, your compliance processes may become more streamlined as the US Food and Drug Administration (FDA) moves to align to ISO 13485. 

 

Background

The FDA announced in 2018 that it was evaluating moving from current good manufacturing practice (CGMP) of the Quality System (QS) Regulation, as set out in 21 CFR part 820, to align more closely with international consensus standard. 

On February 23, 2022, the FDA announced plans to adopt ISO 13485:2016 as well as additional requirements. The new rule will be referred to as the Quality Management System Regulation (QMSR).

 

Impact

The FDA estimates that the proposed rule change will result in annualized net cost savings to medical device companies.  The new rule will be required to be implemented 1 year after going into effect. 

 

Here’s a list of what’s similar and different between ISO13485 and the new QMSR.

 

The proposed rule is similar to the following ISO clauses:

  • Clauses 1-3
  • Clauses 5-6
  • Clauses 8-9

The proposed rule is different than the following ISO clauses:

  • Clause 4, Quality Management System. Specifically Documents and Records.
  • Clause 7. Product Realization. Specifically Design Controls and Servicing.
 
FDA Requirements
  • Clause 4.2.5 will have an additional requirement to include signature and date, whether paper or electronic records.  Complaints and servicing activity records will capture information as per 21 CFR Part 803. The Unique Device Identification (UDI) for each medical device or batch of medical devices will be documented as per 21 CFR Part 830.
  • ISO Clause 7.3 will apply only to manufacturers of class I devices listed in the provision, as well as all class II and class III devices.
  • ISO Clause 7.5.1 will have additional requirements from 820.45 for labeling, packing and inspection of labeling.
  • ISO Clause 7.5.4 will have additional requirements from 820.35(b) for servicing activities.
  • ISO Clause 7.5.9.2 will have an additional requirement for devices that support or sustain life, in addition to ISO’s implantable device requirements. 

 

FDA Terminology Being Removed 

  • Establish. Why? Because ISO’s requirement to document a requirement implies that it is first established, which is sufficient.
  • Management with executive responsibility. Why? Because it’s being replaced with ISO’s top management term.
  • Device Master Record (DMR). Why? Because it’s being replaced with ISO’s Medical Device File term.

 

Terminology Being Kept

  • Act. Specifically there will be an addition of Federal Food Drug and Cosmetic Act.
  • Process validation. Although FDA maps this to the ISO validation of processes term, it notes that the term is not defined by ISO and therefore will be retained as-is. 
  • Customer. This is being defined as component manufacturers, contract manufacturers and end users. 
  • Device. As defined by the FDA.
  • Labeling. As defined by the FDA.
  • Manufacturer. This is being defined as an additional type of Organization.
  • Safety and Effectiveness. This is different than ISO’s safety and performance.
  • Product. As defined by the FDA.
 
Your Plan With Origami

Assess. Take the time to review the planned rule changes, and determine the scope of impacts on your processes. 

Plan. Contact Origami or your consulting partner to plan changes to your system.  There may be entirely new processes to add to your operations, such as risk management and UDI. We’re here to help you by providing you with good practices and examples. 

Budget and Implement. You may allocate people and time to configure system changes, and to conduct training. 

Continually Improve. Change is an opportunity to improve. We have experience and can help you.  Don’t forget to set up a project in Origami to track and status your company’s transition activities and costs.  

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