FDA CFR 21 Part 820

Subpart A: General Provisions
Subpart B: Quality System Requirements
Subpart C: Design Controls
Subpart D: Document Controls
Subpart E: Purchasing Controls
Subpart F: Identification and Traceability
Subpart G: Production and Process Controls
Subpart H: Acceptance Activities
Subpart I: Nonconforming Product
Subpart J: Corrective and Preventative Action
Subpart K: Labeling and Packaging Control
Subpart L: Handling, Storage, Distribution, and Installation
Subpart M: Records
Subpart N: Servicing
Subpart O: Statistical Controls

For latest Electronic Code of Federal Regulations

FDA Guide to Inspection of Quality Systems

Product Development Road Map

Voice of the Customer

Design History File

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User Needs

Design Inputs

Design Outputs

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Verification of Design Inputs

Validation of User Needs

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Device Master Record

Regulatory Submission/Approval

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Design Transfer

Limited & Full Product Launch

Design Controls

IVD Product Development and Design Controls

FDA has provided guidelines for development of medical device products. These guidelines are focused on ensuring that the product development process includes a set of checks and balances to ensure that the developed design, manufacturing processes, and the final product that goes out to the customer is robust. These guidelines are not intended to be a checklist that should be completed prior to submitting for regulatory approval but are expected to become part of a quality culture that is followed during the development and manufacturing of the product. Hence, it is important to understand the framework provided by the FDA. Each product is different. Understanding the framework provided by the FDA will help ensure that irrespective of what the product is, it is safe and effective.

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