What changed when 21 CFR 820 became the QMSR

Part 820 is the Quality Management System Regulation, and it works by incorporating ISO 13485:2016 by reference and adding a short set of FDA-specific requirements in the CFR text itself. Twenty-nine sections of the former Quality System Regulation were removed or reserved in the eCFR issue of 4 February 2026, leaving six operative sections.¹

• § 820.1
• § 820.3
• § 820.7
• § 820.10
• § 820.35
• § 820.45

The practical effect is that the detailed subparts that once carried the substance of the regulation no longer exist. A quality manual, a supplier agreement or a submission that cites § 820.30(g), § 820.100 or § 820.198 is citing text that has been removed from the CFR. The obligation behind each of those citations survives, but it now comes from a clause of ISO 13485 as made applicable by § 820.10(a), sometimes with an added CFR requirement layered on top.¹

Sections removed or reserved

All of the following changes appear in the eCFR issue of 4 February 2026. Two sections were reserved and the remaining twenty-seven were removed outright. A reserved section number holds a place in the CFR and carries no text.¹

Section	Former heading	Status
§ 820.5	Quality system	Reserved
§ 820.20	Management responsibility	Removed
§ 820.22	Quality audit	Removed
§ 820.25	Personnel	Removed
§ 820.30	Design controls	Removed
§ 820.40	Document controls	Reserved
§ 820.50	Purchasing controls	Removed
§ 820.60	Identification	Removed
§ 820.65	Traceability	Removed
§ 820.70	Production and process controls	Removed
§ 820.72	Inspection, measuring, and test equipment	Removed
§ 820.75	Process validation	Removed
§ 820.80	Receiving, in-process, and finished device acceptance	Removed
§ 820.86	Acceptance status	Removed
§ 820.90	Nonconforming product	Removed
§ 820.100	Corrective and preventive action	Removed
§ 820.120	Device labeling	Removed
§ 820.130	Device packaging	Removed
§ 820.140	Handling	Removed
§ 820.150	Storage	Removed
§ 820.160	Distribution	Removed
§ 820.170	Installation	Removed
§ 820.180	General requirements (records)	Removed
§ 820.181	Device master record	Removed
§ 820.184	Device history record	Removed
§ 820.186	Quality system record	Removed
§ 820.198	Complaint files	Removed
§ 820.200	Servicing	Removed
§ 820.250	Statistical techniques	Removed

Where the former requirements now sit

The general answer is § 820.10(a). A manufacturer subject to the part must document a quality management system that complies with the applicable requirements of ISO 13485 and the other applicable requirements of the part.¹ Subject matter that was once spelled out in a numbered CFR section now comes from the corresponding clause of the standard, which is incorporated by reference under § 820.7(b) in its third edition of 1 March 2016.¹

A smaller set of former sections has an explicit successor in the current CFR text. Each pairing below joins a clause of ISO 13485 with the FDA requirement that accompanies it.

• Identification, formerly § 820.60, is Clause 7.5.8 read with § 820.10(b)(1). That section requires a documented system to assign unique device identification in accordance with part 830.¹
• Traceability, formerly § 820.65, is Clause 7.5.9.1 read with § 820.10(b)(2). That section requires documented traceability procedures in accordance with part 821 where applicable.¹
• Complaint files, formerly § 820.198, is Clause 8.2.2 read with § 820.35(a). That section sets out the seven items of information to be recorded. It is also read with § 820.10(b)(3) on notifying FDA of complaints that meet the reporting criteria of part 803.¹
• Servicing, formerly § 820.200, is Clause 7.5.4 read with § 820.35(b). That section sets the minimum content of a servicing record.¹
• Device labeling and device packaging, formerly §§ 820.120 and 820.130, are Clause 7.5.1 read with § 820.45.¹
• Records, formerly § 820.180, are Clause 4.2.5 read with § 820.35.¹ Document controls, formerly § 820.40, come under the general requirement in § 820.10(a).¹
• Design controls, formerly § 820.30, are Clause 7.3 and its subclauses, applied to the devices named in § 820.10(c).¹

Advisory notices are handled under Clauses 7.2.3, 8.2.3 and 8.3.3 in accordance with part 806, by § 820.10(b)(4).¹ Traceability for implantable devices under Clause 7.5.9.2 applies to manufacturers of devices that support or sustain life, where failure to perform when properly used in accordance with the labeling can reasonably be expected to result in significant injury, by § 820.10(d).¹

The remaining removed sections have no named counterpart in the CFR text. The following are now matters for the corresponding requirements of ISO 13485 as documented under § 820.10(a).¹

• management responsibility
• quality audit
• personnel
• purchasing controls
• production and process controls
• process validation
• acceptance activities
• nonconforming product
• corrective and preventive action
• handling
• storage
• distribution
• installation
• statistical techniques

Terms that no longer appear in the regulation

The vocabulary of the former regulation went with the sections that carried it. The current part 820 text contains no device master record, no device history record, no design history file and no quality system record. Where the CFR text needs to refer to the compiled documentation for a device it uses the medical device file, which appears in the definition of rework in § 820.3(b) and in § 820.45(c).¹

Definitions now come from two directions. ISO 13485 and Clause 3 of ISO 9000 supply the general vocabulary of the part.¹ Section 820.3(b) then overrides several of those terms: all definitions in section 201 of the Federal Food, Drug, and Cosmetic Act supersede the correlating ISO terms, so the statutory definitions of device and labeling control over the standard’s medical device and labelling.¹ Organization takes the meaning of manufacturer as defined in the part, implantable medical device takes the meaning of implant in § 860.3, and safety and performance takes the meaning of safety and effectiveness in Clause 0.1 of ISO 13485.¹ Section 820.1(a) states that use of terminology such as safety and performance does not change the statutory standard or the requirements of the part.¹ Six terms survive in § 820.3(a) because ISO does not use or define them: batch or lot, component, Federal Food, Drug, and Cosmetic Act, finished device, HCT/P regulated as a device and remanufacturer.¹

What stayed in the CFR

Scope in § 820.1 remains a CFR provision. The part governs the following activities for all finished devices intended for human use.¹

• design
• manufacture
• packaging
• labeling
• storage
• installation
• servicing

It reaches the following.¹

• contract sterilizers
• installers
• relabelers
• remanufacturers
• repackers
• specification developers
• initial distributors of foreign entities performing those functions

Manufacturers of components or parts fall outside the part and are encouraged to consider its provisions as appropriate.¹ Manufacturers of blood and blood components for transfusion or further manufacturing are subject to subchapter F instead.¹

The conflict rule in § 820.1(b) is worth reading closely by anyone working from the standard. Where a clause of ISO 13485 conflicts with the Federal Food, Drug, and Cosmetic Act or its other implementing regulations, the Act and those regulations control.¹ Within the chapter, the requirements specifically applicable to the device in question supersede the more generally applicable requirements.¹

Exemptions and variances stay in § 820.1(d). A manufacturer may petition for an exemption or variance under section 520(f)(2) of the Act, using the procedures in § 10.30.¹ FDA may also initiate and grant a variance where it determines the variance is in the best interest of public health, including where there is a public health need for the device and the device would not likely be made sufficiently available otherwise.¹

Enforcement remains where it was. Under § 820.10(e), failure to comply with any applicable requirement in the part renders a device adulterated under section 501(h) of the Act, and the device and any person responsible are subject to regulatory action.¹

Design and development scope

Design and development under Clause 7.3 and its subclauses applies to manufacturers of class II and class III devices.¹ Among class I devices it applies to those automated with computer software and to five listed device types.¹

• the tracheobronchial suction catheter in § 868.6810
• the non-powdered surgeon’s glove in § 878.4460
• the protective restraint in § 880.6760
• the manual radionuclide applicator system in § 892.5650
• the radionuclide teletherapy source in § 892.5740

No other class I device falls within Clause 7.3 by force of this part.¹

Questions people also ask

Are the old QSR section numbers still valid citations?

No. Twenty-seven sections were removed and §§ 820.5 and 820.40 were reserved in the eCFR issue of 4 February 2026.¹ A reference to § 820.30, § 820.50, § 820.100, § 820.181 or § 820.184 points to text that is no longer in the CFR. The operative sections of part 820 are the following.¹

• § 820.1
• § 820.3
• § 820.7
• § 820.10
• § 820.35
• § 820.45

Does compliance with ISO 13485 alone satisfy 21 CFR part 820?

It does not. Section 820.10(a) requires a documented quality management system complying with ISO 13485 and with the other applicable requirements of the part.¹ Those other requirements include the cross-references to parts 803, 806, 821 and 830 in § 820.10(b), the record content in § 820.35 and the labeling and packaging controls in § 820.45.¹ Section 820.3(b) also replaces several ISO definitions with the statutory ones.¹

Is the device master record still required?

The term no longer appears in part 820. The regulation refers instead to the medical device file, which is named in the definition of rework in § 820.3(b) and in the labeling and packaging controls in § 820.45(c).¹ Section 820.45(c) requires inspection of labeling and packaging before use to assure that all devices have correct labeling and packaging as specified in the medical device file.¹

What complaint information must still be recorded under the CFR?

Section 820.35(a) requires records of the review, evaluation and investigation of complaints involving the possible failure of a device, labeling or packaging to meet specifications.¹ Where an investigation has already been performed for a similar complaint, another is not necessary, and the manufacturer maintains records documenting the justification.¹ The recorded items are the device name, the date received, any UDI or UPC and other identification, the complainant’s name, address and phone number, the nature and details of the complaint, any correction or corrective action, and any reply.¹

Which edition of ISO 13485 is incorporated?

Section 820.7(b) incorporates ISO 13485:2016(E), third edition, dated 1 March 2016.¹ The incorporation is approved for §§ 820.1, 820.3, 820.10, 820.35 and 820.45. Section 820.7(a) separately incorporates Clause 3 of ISO 9000:2015(E), fourth edition, dated 15 September 2015. That incorporation is approved for § 820.3.¹ The material is available from ISO and for inspection at FDA and the National Archives and Records Administration.¹

Footnotes

1. 21 CFR Part 820, Quality Management System Regulation. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³ ↩²⁴ ↩²⁵ ↩²⁶ ↩²⁷ ↩²⁸ ↩²⁹ ↩³⁰ ↩³¹ ↩³² ↩³³ ↩³⁴ ↩³⁵ ↩³⁶ ↩³⁷ ↩³⁸ ↩³⁹ ↩⁴⁰ ↩⁴¹ ↩⁴² ↩⁴³ ↩⁴⁴ ↩⁴⁵ ↩⁴⁶ ↩⁴⁷