Medical Device Quality System 21 CFR 820

This blog talks about the medical device regulations and there are many regulations and guidelines which sponsors (companies, manufacturers) are obligated to comply with when they manufacturer or import products in or into the US respectively. Let us start with the Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR Part 820.  This 21 CFR Part 820 is the key regulation pertains to medical device quality system in the US.

Per (1)- “The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements”.

Since this is a big topic. There will be several blogs to discuss each subpart of 21 CFR Part 820. The following subparts for 21 CFR Part 820 are tabulated below. If warranted, each subpart shall be discussed in subsequently blog in more detail.  The Subparts are shown below(2):

21 CFR 820 Quality System Regulation(2)

Subpart A—General Provisions	Sec. 820.1 Scope, Sec. 820.3 Definitions., Sec. 820.5 Quality system.
Subpart B—Quality System Requirements	Sec. 820.20 Management responsibility, Sec. 820.22 Quality audit, Sec. 820.25 Personnel.
Subpart C--Design Controls	Sec. 820.30 Design controls.
Subpart D--Document Controls	Sec. 820.40 Document controls.
Subpart E--Purchasing Controls	Sec. 820.50 Purchasing controls.
Subpart F—Identification and Traceability	Sec. 820.60 Identification, Sec. 820.65 Traceability.
Subpart G--Production and Process Controls	Sec. 820.70 Production and process controls. Sec. 820.72 Inspection, measuring, and test equipment.
Subpart H--Acceptance Activities	Sec. 820.80 Receiving, in-process, and finished device acceptance. Sec. 820.86 Acceptance status.
Subpart I--Nonconforming Product	Sec. 820.90 Nonconforming product.
Subpart J--Corrective and Preventive Action	Sec. 820.100 Corrective and preventive action.
Subpart K--Labeling and Packaging Control	Sec. 820.120 Device labeling. Sec. 820.130 Device packaging.
Subpart L--Handling, Storage, Distribution, and Installation	Sec. 820.140 Handling. Sec. 820.150 Storage. Sec. 820.160 Distribution. Sec. 820.170 Installation.
Subpart M--Records	Sec. 820.180 General requirements. Sec. 820.181 Device master record. Sec. 820.184 Device history record. Sec. 820.186 Quality system record. Sec. 820.198 Complaint files.
Subpart N--Servicing	Sec. 820.200 Servicing.
Subpart O--Statistical Techniques	Sec. 820.250 Statistical techniques.

 1.     –Overview of Device Regulation, US, Food and Drug Administration, www.fda.gov, page last
updated: 06/26/2014.

2.     –21 CFR 820 Qualtiy System Regulation, US, Food and Drug Administration, www.fda.gov, page
last 06/01/2013.  

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.