Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10119 

(i) Related Information 

(1) For more information about this AD, 

contact Dorie Resnik, Aerospace Engineer, 

Boston ACO Branch, 1200 District Avenue, 

Burlington, Massachusetts 01803; telephone 

781–238–7693; email 9-AVS-AIR-BACOCOS@faa.gov. 

(2) For service information identified in 

this AD, contact Sikorsky’s Engineering 

Group Sikorsky Aircraft Corporation, 124 

Quarry Road, Trumbell, CT, 06611, United 

States; phone: (800) 946–4337; email: wcs_

cust_service_eng.gr-sik@lmco.com; website: 

www.sikorsky360.com. You may view this 

referenced service information at the FAA, 

Office of the Regional Counsel, Southwest 

Region, 10101 Hillwood Pkwy, Room 6N– 

321, Fort Worth, TX 76177. For information 

on the availability of this material at the 

FAA, call (817) 222–5110. 

Issued on February 16, 2022. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2022–03769 Filed 2–22–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 4 and 820 

[Docket No. FDA–2021–N–0507] 

RIN 0910–AH99 

Medical Devices; Quality System 

Regulation Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to amend the device 

current good manufacturing practice 

(CGMP) requirements of the Quality 

System (QS) Regulation to align more 

closely with the international consensus 

standard for devices by converging with 

the quality management system (QMS) 

requirements used by other regulatory 

authorities from other jurisdictions (i.e., 

other countries). We propose to do so 

through incorporating by reference an 

international standard specific for 

device quality management systems set 

by the International Organization for 

Standardization (ISO), the 2016 edition 

of ISO 13485 (ISO 13485). Through this 

rulemaking we also propose additional 

requirements to align with existing 

requirements in the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) and its 

implementing regulations, and make 

conforming edits to the Code of Federal 

Regulations (CFR) to clarify the device 

CGMP requirements for combination 

products. This action, if finalized, will 

continue our efforts to align our 

regulatory framework with that used by 

other regulatory authorities to promote 

consistency in the regulation of devices 

and provide timelier introduction of 

safe, effective, high-quality devices for 

patients. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by May 24, 2022. Submit written 

comments (including recommendations) 

on the collection of information under 

the Paperwork Reduction Act of 1995 

(PRA) by March 25, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 24, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 24, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0507 for ‘‘Medical Devices; 

Quality System Regulation 

Amendments.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10120 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

Submit comments on information 

collection under the PRA to the Office 

of Management and Budget (OMB) at 

https://www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. The title of this 

proposed collection is ‘‘Medical 

Devices; Quality Management System.’’ 

FOR FURTHER INFORMATION CONTACT: 

With regard to the proposed rule: Keisha 

Thomas or Melissa Torres, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903, 301–796–2001, Proposed-DeviceQMSR-Rule@fda.hhs.gov. 

With regard to the information 

collection: Amber Sanford, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

8867, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

III. Background 

A. Introduction 

B. Need for the Regulation 

C. FDA’s Current Regulatory Framework 

D. History of the Rulemaking 

E. Incorporation by Reference 

IV. Legal Authority 

V. Description of the Proposed Rule 

A. Scope (Proposed § 820.1) 

B. Definitions (Proposed § 820.3) 

C. Incorporation by Reference (Proposed 

§ 820.7) 

D. Proposed Requirements for a Quality 

Management System (Proposed § 820.10) 

E. Proposed Clarification of Concepts 

(Proposed § 820.15) 

F. Proposed Supplementary Provisions 

(Proposed Subpart B) 

G. Proposed Conforming Amendments 

VI. Proposed Effective Date and 

Implementation Strategy 

VII. Preliminary Economic Analysis of 

Impacts 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA has historically recognized the 

benefits of harmonization with other 

regulatory authorities and over time has 

taken a number of actions to promote 

consistency with its regulatory 

counterparts. As part of such activities, 

FDA is proposing to revise its device 

CGMP requirements as set forth in the 

QS regulation, codified in part 820 (21 

CFR part 820). Through this proposed 

rulemaking, FDA intends to converge its 

requirements with quality management 

system requirements used by other 

regulatory authorities. FDA seeks to 

accomplish this primarily by 

incorporating by reference the 2016 

edition of International Organization for 

Standardization (ISO) 13485 (ISO 

13485). This rule, if finalized, would 

harmonize quality management system 

requirements for devices with 

requirements used by other regulatory 

authorities. Such harmonization should 

provide patients more efficient access to 

necessary devices, leading to 

improvement of life quality of the 

consumers. 

B. Summary of the Major Provisions of 

the Proposed Rule 

We are proposing to amend the 

current part 820, primarily, through 

incorporating by reference the quality 

management system requirements of 

ISO 13485. We have determined that the 

requirements in ISO 13485 are, when 

taken in totality, substantially similar to 

the requirements of the current part 820, 

providing a similar level of assurance in 

a firm’s quality management system and 

ability to consistently manufacture 

devices that are safe and effective and 

otherwise in compliance with the FD&C 

Act. As such, we propose to withdraw 

the requirements in the current part 820, 

except that we propose to retain the 

scope of the current regulation and to 

retain and modify, as indicated below, 

a number of the definitions in the 

current part 820. We are also proposing 

to amend the title of the regulation and 

add FDA-specific requirements and 

provisions that clarify certain concepts 

used in ISO 13485. The result will be 

referred to as the Quality Management 

System Regulation (QMSR). These 

additions will ensure that the 

incorporation by reference of ISO 13485 

does not create inconsistencies with 

other applicable FDA requirements. 

FDA is also proposing conforming edits 

to part 4 (21 CFR part 4) to clarify the 

device QMS requirements for 

combination products. These edits 

would not impact the CGMP 

requirements for combination products. 

The rule, if finalized, would converge 

QS regulation with the QMS 

requirements of ISO 13485, while 

continuing to provide the same level of 

assurance of safety and effectiveness 

under the FD&C Act and its 

implementing regulations. The Agency 

solicits comments on specific subject 

areas related to this proposed rule that 

FDA should consider in seeking to 

converge U.S. requirements with 

requirements used by other regulatory 

authorities in ways that are consistent 

with FDA’s authority under the FD&C 

Act. 

C. Legal Authority 

We are proposing to issue this rule 

under the same authority that FDA 

initially invoked to issue the current 

part 820 and combination product 

regulations, as well as the general 

administrative provisions of the FD&C 

Act (21 U.S.C. 351, 352, 360, 360c, 

360d, 360e, 360h, 360i, 360j, 360l, 371, 

374, 381, 383; 42 U.S.C. 216, 262, 263a, 

264). 

D. Costs and Benefits 

We estimate that the proposed rule 

will result in an annualized net cost 

savings (benefits) of approximately $439 

million over 10 years at a discount rate 

of 3 percent. When we assume a 

discount rate of 7 percent, the 

annualized net cost savings are 

approximately $533 million. The benefit 

of the proposed rule is estimated in 

terms of reduction of compliance effort, 

and consequently cost savings, for 

medical device establishments that 

currently comply with both standards. 

The costs of the rule include initial 

training of personnel, and information 

technology and documentation update 

for the medical device industry and the 

FDA. There is also a one-time cost of 

reading and learning the rule for the 

medical device establishments. 

If finalized, in addition to the cost 

savings to the medical device industry, 

the qualitative benefits of the proposed 

rule include quicker access to newly 

developed medical devices for patients, 

leading to improvement of life quality of 

the consumers. The proposed rule, if 

finalized, would also align the current 

part 820 with other related programs 

potentially contributing to additional 

cost savings. 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10121 

Abbreviation/acronym What it means 

ANSI .................................................................................. American National Standards Institute. 

CD ..................................................................................... Committee Draft. 

CFR ................................................................................... Code of Federal Regulations. 

CGMP ................................................................................ Current Good Manufacturing Practice. 

DGMP ................................................................................ Device Good Manufacturing Practice. 

DMR .................................................................................. Device Master Record. 

FD&C Act .......................................................................... Federal Food, Drug, and Cosmetic Act. 

FDA ................................................................................... Food and Drug Administration. 

GHTF ................................................................................. Global Harmonization Task Force. 

GMP .................................................................................. Good Manufacturing Practice. 

IBR .................................................................................... Incorporated by Reference. 

IMDRF ............................................................................... International Medical Device Regulators Forum. 

ISO .................................................................................... International Organization for Standardization. 

ISO 13485 ......................................................................... International Organization for Standardization 13485:2016. 

ISO 9000 ........................................................................... Quality Management Systems—Fundamentals and Vocabulary,’’ ISO 9000:2015. 

MDSAP .............................................................................. Medical Device Single Audit Program. 

NARA ................................................................................ National Archives and Records Administration. 

OMB .................................................................................. Office of Management and Budget. 

QMS .................................................................................. Quality Management System. 

QMSR ................................................................................ Quality Management System Regulation. 

QS ..................................................................................... Quality System. 

QSIT .................................................................................. Quality System Inspection Technique. 

SMDA ................................................................................ Safe Medical Devices Act of 1990. 

UDI .................................................................................... Unique Device Identification. 

III. Background 

A. Introduction 

QMSs specify requirements to help 

manufacturers ensure that their 

products consistently meet applicable 

customer and regulatory requirements 

and specifications (Ref. 1). In the United 

States, authority for the QS regulation 

for devices is found under section 520(f) 

of the FD&C Act (21 U.S.C. 360j(f)), 

which the FD&C Act refers to as CGMP 

requirements. FDA issued a final rule 

for CGMP requirements in the Federal 

Register of July 21, 1978 (43 FR 31508), 

which created part 820 (Ref. 2). 

As described below, FDA significantly 

revised part 820 in a final rule 

published in the Federal Register of 

October 7, 1996 (61 FR 52602, effective 

June 1, 1997) (1996 Final Rule), 

establishing the current QS regulation. 

As revised, part 820 includes 

requirements related to the methods 

used in, and the facilities and controls 

used for, designing, manufacturing, 

packaging, labeling, storing, installing, 

and servicing of devices intended for 

human use. These requirements are 

intended to assure that devices are safe 

and effective and otherwise in 

compliance with the FD&C Act. FDA 

has not undertaken a significant 

revision of part 820 since the 1996 Final 

Rule. Part 820 has been an effective 

regulation, providing assurance that 

devices are safe and effective and 

otherwise in compliance with 

applicable sections of the FD&C Act. 

Also in 1996, ISO issued the first 

version of ISO 13485, ‘‘Quality 

systems—Medical devices—Particular 

requirements for the application of ISO 

9001,’’ as a voluntary consensus 

standard to specify, in conjunction with 

the application of ISO 9001, the QMS 

requirements for the design/ 

development and, when relevant, 

installation and servicing of medical 

devices (Refs. 3 and 4). Over time, ISO 

13485 has evolved into a stand-alone 

standard outlining QMS requirements 

for devices (Ref. 1). With each revision, 

ISO 13485 has become more closely 

aligned with, and similar to, the 

requirements in part 820. This 

alignment and similarity are particularly 

true for the 2016 version of ISO 13485. 

Recognizing this progression, FDA sees 

an opportunity for regulatory 

harmonization by proposing to amend 

the current part 820 regulation to 

explicitly incorporate the QMS 

requirements of ISO 13485. ISO 13485 

is used internationally by many 

regulatory authorities either as a 

foundation for or as that country’s QMS 

requirements for device manufacturers 

and is utilized in regulatory 

harmonization programs such as the 

Medical Device Single Audit Program 

(MDSAP), in which FDA and regulatory 

authorities from four other countries 

participate (Ref. 5). 

The current part 820 applies to many 

different devices and thus does not 

prescribe in detail how a manufacturer 

must design and manufacture a specific 

device. Rather, the regulation was 

developed to be a mandatory and 

flexible framework, requiring 

manufacturers to develop and follow 

procedures and processes, as 

appropriate to a given device, according 

to the state-of-the-art for manufacturing 

and designing such device. Successful 

compliance with this regulation 

provides the manufacturer with a 

framework for achieving quality 

throughout the organization (Ref. 1). 

While part 820 effectively addresses 

the requirements for a QMS, FDA has 

long recognized the value of, and has 

been exploring ways to effect, global 

harmonization for the regulation of 

devices. For example, FDA has actively 

participated in the development of 

internationally harmonized documents 

and standards on risk management since 

their inception, including the 

development of the Global 

Harmonization Task Force (GHTF) 

guidance document, ‘‘Implementation of 

Risk Management Principles and 

Activities Within a Quality Management 

System,’’ dated May 20, 2005, which 

outlines the integration of a risk 

management system into a QMS (Ref. 6). 

FDA also participated in the 

development of the various versions of 

ISO 14971 ‘‘Medical Devices— 

Application of Risk Management to 

Medical Devices’’ (Ref. 7). 

In 2012, FDA developed a voluntary 

audit report submission pilot program, 

which is no longer operational, in 

which FDA accepted a manufacturer’s 

ISO 13485:2003 audit report (Ref. 8). 

Through this program, FDA established 

the feasibility and use of ISO 13485 

audit reports in lieu of FDA’s routine 

inspections covering the QS regulation 

requirements. Additionally, FDA 

participates in the International Medical 

Device Regulators Forum (IMDRF), a 

voluntary group of medical device 

regulators from around the world 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10122 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

focused on regulatory harmonization 

and convergence (Ref. 9). IMDRF 

developed MDSAP in 2012. Under 

MDSAP, audits are conducted based on 

core ISO 13485 requirements with 

additional country-specific 

requirements. In determining whether to 

participate in MDSAP and which FDAspecific provisions were needed for the 

United States, FDA conducted a 

thorough review and comparison of ISO 

13485 and part 820 and concluded that 

very few FDA-specific requirements 

needed to be added to this audit model, 

demonstrating not only the similarities 

between the current part 820 and ISO 

13485, but the comprehensive QMS 

approach provided by ISO 13485. This 

has allowed FDA to participate in 

MDSAP and accept certain MDSAP 

audits as a substitute for its own routine 

surveillance of device quality systems 

(Ref. 5). 

Through our participation in MDSAP, 

FDA has gained experience with ISO 

13485 and determined that it provides 

a comprehensive and effective approach 

to establish a QMS for devices. As such, 

FDA is proposing to amend the device 

CGMP requirements of the QS 

regulation by incorporating by reference 

the 2016 edition of ISO 13485 as well 

as proposing additional regulations that 

help connect and align ISO 13485 with 

other FDA requirements. The 2016 

version of ISO 13485 provides 

requirements for a QMS that allow a 

manufacturer to demonstrate its ability 

to provide devices and related services 

that consistently meet customer 

requirements and regulatory 

requirements applicable to such devices 

and services (Ref. 1). These 

requirements can be used by ‘‘an 

organization involved in one or more 

stages of the life cycle of a medical 

device, including design and 

development, production, storage and 

distribution, installation, servicing and 

final decommissioning and disposal of 

medical devices’’ (Ref. 1). 

FDA believes that globally 

harmonizing the regulation of devices 

will help provide consistent, safe, and 

effective devices, contributing to public 

health through timelier access for 

patients. Harmonizing differing 

regulations would remove unnecessary 

duplicative regulatory requirements and 

impediments to market access and 

remove barriers to patient access and 

costs. The more flexible approach to 

quality, based on risk management, 

found within ISO 13485 will meet the 

needs of patients to have access to 

quality devices in consonance with the 

progress of science and technology (Ref. 

9). 

B. Need for the Regulation 

Currently, device manufacturers 

registered with the FDA must comply 

with the current part 820. In addition to 

the current part 820, registered 

manufacturers in many other 

jurisdictions and domestic 

manufacturers that export devices must 

comply with ISO 13485, which is 

substantially similar to the current part 

820. As a result, there is redundant 

effort for some manufacturers in 

complying with both the current part 

820 and ISO 13485. The redundancy of 

effort to comply with two substantially 

similar requirements creates 

inefficiency. In order to address this 

inefficiency, we propose to incorporate 

by reference ISO 13485 requirements so 

that compliance with ISO 13485 would 

satisfy requirements of current part 820. 

Although the requirements under the 

current part 820 are effective and very 

similar to those in ISO 13485, 

incorporating ISO 13485 by reference 

would further the Agency’s goals for 

regulatory simplicity and global 

harmonization and should reduce 

burdens on regulated industry, thereby 

providing patients more efficient access 

to necessary devices (Ref. 9). 

C. FDA’s Current Regulatory Framework 

The FD&C Act, as amended, and its 

implementing regulations establish a 

comprehensive system for the regulation 

of devices intended for human use. The 

device CGMP requirements in the 

current part 820 were authorized by 

section 520(f) of the FD&C Act, which 

was among the authorities added to the 

FD&C Act by the Medical Device 

Amendments of 1976 (Pub. L. 94–295). 

Under section 520(f) of the FD&C Act, 

FDA issued the current part 820 

regulation, which was last revised in 

1996. 

In addition, section 520(f)(1)(B) of the 

FD&C Act directs the Agency to afford 

the Device Good Manufacturing Practice 

Advisory Committee (DGMP Advisory 

Committee) an opportunity to submit 

recommendations for proposed CGMP 

regulations, to afford an opportunity for 

an oral hearing, and to ensure that such 

regulations conform, to the extent 

practicable, with internationally 

recognized standards defining quality 

management systems, or parts of the 

standards, for devices (see 21 U.S.C. 

360j(f)(1)(B)). The DGMP Advisory 

Committee reviews regulations 

proposed for promulgation regarding 

good manufacturing practices and 

makes recommendations to the Agency 

regarding the feasibility and 

reasonableness of the proposed 

regulations. The Agency will convene a 

DGMP Advisory Committee meeting 

and afford an opportunity for an oral 

hearing to discuss this proposal prior to 

FDA’s finalization of this rule. 

Further, the provisions of sections 

501(a)(2)(B) and (h) of the FD&C Act (21 

U.S.C. 351(a)(2)(B) and (h)) require the 

manufacture of drugs and devices to 

comply with CGMP requirements, and 

section 520(f) of the FD&C Act 

specifically authorizes the issuance of 

CGMP regulations for devices, including 

device constituent parts of products that 

constitute a combination of a drug, 

device, and/or biological product, as 

defined in § 3.2(e) (21 CFR 3.2(e)) 

(‘‘combination products’’). Combination 

products that include device constituent 

parts have a distinct regulatory 

framework for CGMP requirements 

because the product, by definition, also 

includes non-device constituent parts 

(e.g., a drug or a biological product). In 

the Federal Register of January 22, 2013 

(78 FR 4307), we issued a final rule 

codifying the CGMP requirements 

applicable to combination products at 

part 4. We issued the part 4 regulations, 

in part, under sections 501(a)(2)(B) and 

(h) and 520(f) of the FD&C Act and are 

proposing to amend part 4 under the 

same authorities. 

In that final rule, we explained that 

the CGMP requirements specific to each 

constituent part of a combination 

product also apply to the combination 

product itself because, by definition, 

combination products consist of drugs, 

devices, and/or biological products (see 

78 FR 4307 at 4320, citing § 3.2(e)). We 

also explained that, because the 

constituent parts of a combination 

product retain their regulatory status (as 

a drug or device, for example) after they 

are combined, all combination products 

are subject to at least two sets of CGMP 

requirements, but that those for drugs 

overlap considerably with the part 820 

requirements for devices (see 78 FR 

4307 at 4320). Part 4 clarifies the 

applicability of the various CGMP 

requirements to provide a streamlined 

option for practical implementation for 

co-packaged and single-entity 

combination products (see 78 FR 4307 

at 4320 and § 4.4 (21 CFR 4.4)). Because 

of the similarity of the drug and device 

CGMP requirements, FDA considers 

demonstrating compliance with one of 

these two sets of regulations (e.g., device 

CGMP requirements) along with 

demonstrating compliance with the 

specified provisions from the other set 

(e.g., drug CGMP requirements) 

identified in part 4 as demonstrating 

compliance with all CGMP 

requirements from both sets (see 78 FR 

4307 at 4320 and § 4.4). 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10123 

D. History of the Rulemaking 

This proposed rulemaking is the first 

revision of the current part 820 since 

1996. As previously described, FDA has 

had a longstanding interest and history 

of participation in efforts to harmonize 

its regulatory requirements with the 

requirements used by other regulatory 

authorities from various jurisdictions 

(i.e., other countries). This rulemaking 

is a continuation of these efforts and, if 

finalized, will harmonize FDA’s quality 

management system regulation with 

requirements of the international 

standard ISO 13485, which is used by 

other regulatory authorities. 

Harmonizing the FDA standard with the 

ISO standard would have benefits for 

manufacturers because many firms 

producing devices for sale within the 

United States and abroad have to 

comply with both standards. If 

finalized, this rule would require 

compliance with an aligned set of 

requirements, instead of two different 

requirements. 

On July 21, 1978, FDA issued a final 

rule in the Federal Register (43 FR 

31508), establishing CGMP 

requirements for medical devices under 

section 520(f) of the FD&C Act. This rule 

became effective on December 18, 1978, 

and is codified under part 820. 

The Safe Medical Devices Act of 1990 

(SMDA) (Pub. L. 101–629) amended 

section 520(f) of the FD&C Act to 

provide FDA with the authority to add 

preproduction design controls to the 

CGMP regulation. This change in law 

was based on findings that a significant 

proportion of device recalls were 

attributable to faulty product design. 

The SMDA also added section 803 to 

the FD&C Act, which, among other 

things, authorizes the Agency to enter 

into agreements with foreign countries 

to facilitate commerce in devices, and in 

such agreements, FDA must encourage 

the mutual recognition of GMP 

regulations under section 520(f) of the 

FD&C Act (see 21 U.S.C. 383(b)(1)). 

To implement the SMDA changes to 

section 520(f) of the FD&C Act, FDA 

revised part 820 by the 1996 Final Rule 

(61 FR 52602). This final rule revised 

the CGMP requirements for medical 

devices and promulgated the QS 

regulation under part 820 in its current 

form. As part of this revision, FDA 

added the design controls authorized by 

the SMDA in addition to other changes 

to achieve consistency with QMS 

requirements worldwide. At the time, 

the Agency sought to harmonize the 

CGMP regulations, to the extent 

possible, with the requirements for 

quality management systems contained 

in then-applicable international 

standards. In particular, FDA worked 

closely with the GHTF and ISO 

Technical Committee 210 (TC 210) to 

develop a regulation consistent with 

both ISO 9001:1994, Quality Systems— 

Model for Quality Assurance in Design, 

Development, Production, Installation, 

and Servicing; and the ISO committee 

draft (CD) revision of ISO/CD 13485 

Quality Systems—Medical Devices— 

Supplementary Requirements to ISO 

9001 (see 61 FR 52602 at 52604). 

E. Incorporation by Reference 

FDA is proposing to incorporate by 

reference ISO 13485:2016 Medical 

devices—Quality management 

systems—Requirements for regulatory 

purposes, Third Edition 2016–03–01. 

ISO is an independent, nongovernmental international organization 

with a membership of national 

standards bodies. ISO 13485 specifies 

requirements for a QMS that can be 

used by a manufacturer involved in one 

or more stages of the life cycle of a 

medical device, including design and 

development, production, storage and 

distribution, installation, servicing and 

final decommissioning and disposal of 

medical devices, or provision of 

associated activities. 

You may view the material at the 

Dockets Management Staff, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

240–420–7500. The material can also be 

found in a read-only format at the 

American National Standards Institute 

(ANSI) Incorporated by Reference (IBR) 

Portal, https://ibr.ansi.org/Standards/ 

iso1.aspx, or you may purchase a copy 

of the material from the International 

Organization for Standardization, BIBC 

II, Chemin de Blandonnet 8, CP 401, 

1214 Vernier, Geneva, Switzerland; 

+41–22–749–01–11; customerservice@

iso.org, https://www.iso.org/store.html. 

ISO 13485 provides a comprehensive 

approach to establish a QMS for medical 

devices. 

FDA is proposing to incorporate by 

reference the current 2016 version of 

ISO 13485. Any future revisions to this 

standard would need to be evaluated to 

determine the impact of the changes and 

whether this rule, if finalized, should be 

amended. If deemed necessary and 

appropriate, FDA will update the final 

regulation in accordance with the 

Administrative Procedure Act (5 U.S.C. 

553) and obtain approval of any changes 

to the incorporation by reference in 

accordance with 1 CFR part 51. 

IV. Legal Authority 

We are proposing to issue this rule 

under the same authority that FDA 

initially invoked to issue the current 

Quality System Regulation (part 820) 

and Regulation of Combination Products 

(part 4), as well as the general 

administrative provisions of the FD&C 

Act: 21 U.S.C. 351, 352, 360, 360c, 360d, 

360e, 360h, 360i, 360j, 360l, 371, 374, 

381, 383; 42 U.S.C. 216, 262, 263a, 264. 

V. Description of the Proposed Rule 

We are proposing to amend the 

current part 820, primarily to 

incorporate by reference ISO 13485, 

Medical Devices—Quality Management 

System Requirements for Regulatory 

Purposes. While the current part 820 

provides sufficient and effective 

requirements for the establishment and 

maintenance of a QMS, regulatory 

expectations for a QMS have evolved 

since the current part 820 was 

implemented over 20 years ago. By 

proposing to incorporate ISO 13485 by 

reference, we are seeking to explicitly 

require current internationally 

recognized regulatory expectations for 

QMS for devices subject to FDA’s 

jurisdiction. The resulting regulation 

will be referred to as the QMSR. 

The current part 820 requirements 

are, when taken in totality, substantially 

similar to the requirements of ISO 

13485. Where ISO 13485 diverges from 

the current part 820, these differences 

are generally consistent with the overall 

intent and purposes behind FDA’s 

regulation of QMSs. Almost all 

requirements in the current part 820 

correspond to requirements within ISO 

13485. Therefore, we are proposing to 

amend the current part 820 by 

withdrawing the majority of the 

requirements for establishing and 

maintaining a QS. Despite these 

changes, this proposal does not 

fundamentally alter the requirements for 

a QS that exist in the current part 820. 

The rule, if finalized, would converge 

QS regulation with the QMS 

requirements of ISO 13485, while 

continuing to provide the same level of 

assurance of safety and effectiveness 

under the FD&C Act and its 

implementing regulations. 

However, we recognize that reliance 

on ISO 13485 without clarification or 

modification could create 

inconsistencies with FDA’s statutory 

and regulatory framework. Therefore, as 

detailed in this rulemaking, we are 

proposing additional definitions, 

clarifying concepts, and additional 

requirements, all of which would 

require compliance within a 

manufacturer’s QMS in addition to ISO 

13485. The Agency solicits comments 

on specific subject areas related to this 

proposed rule that FDA should consider 

in seeking to converge U.S. 

requirements with requirements used by 

other regulatory authorities in ways that 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10124 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

are consistent with FDA’s authority 

under the FD&C Act. 

Our approach to this rulemaking is to 

simplify and streamline the regulation. 

Where possible, we either are proposing 

to accept the incorporated requirement 

without modification or are proposing a 

requirement that will supersede the 

correlating requirement in ISO 13485. 

There are a few exceptions where we are 

proposing to clarify concepts or 

augment specific clauses in ISO 13485, 

but overall, we are not proposing to 

modify the clauses in ISO 13485. (see 

table 1). This philosophy also helps 

further regulatory convergence. 

As discussed further in section VI., 

this rule is only proposing to amend the 

current part 820 and does not impact 

our inspectional authority under section 

704 of the FD&C Act (21 U.S.C. 374). We 

are also proposing conforming edits to 

part 4 to clarify the device QMS 

requirements for combination products. 

These edits would not impact the CGMP 

requirements for combination products. 

TABLE 1—HIGH-LEVEL SUMMARY OF 21 CFR PART 820 PROPOSED RULE DIFFERENCES AND ADDITIONS

Current part 820 1 ISO 13485 requirements 1 Proposed rule 

Subpart A—General Provisions ................................ Clause 1. Scope, Clause 4. Quality Management 

System.

Requirements substantively similar. 

Subpart B—QS Requirements .................................. Clause 4. Quality Management System, Clause 5. 

Management Responsibility, Clause 6. Resource 

Management, Clause 8. Measurement, Analysis, 

and Improvement.

Requirements substantively similar. 

Subpart C—Design Controls ..................................... Clause 7. Product Realization .................................. Requirements substantively similar. 

Subpart D—Document Controls 2 .............................. Clause 4. Quality Management System ................... Differences addressed in 820.35. 

Subpart E—Purchasing Controls .............................. Clause 7. Product Realization .................................. Requirements substantively similar. 

Subpart F—Identification and Traceability ................ Clause 7. Product Realization .................................. Requirements substantively similar. 

Subpart G—Production and Process Controls .......... Clause 4. Quality Management System, Clause 6. 

Resource Management, Clause 7. Product Realization.

Requirements substantively similar. 

Subpart H—Acceptance Activities ............................. Clause 7. Product Realization, Clause 8. Measurement, Analysis, and Improvement.Requirements substantively similar. 

Subpart I—Nonconforming Product .......................... Clause 8. Measurement, Analysis, and Improvement.Requirements substantively similar. 

Subpart J—Corrective and Preventive Action ........... Clause 8. Measurement, Analysis, and Improvement.Requirements substantively similar. 

Subpart K—Labeling and Packaging Control ........... Clause 7. Product Realization .................................. Differences addressed in 820.45. 

Subpart L—Handling, Storage, Distribution, and Installation.Clause 7. Product Realization .................................. Requirements substantively similar. 

Subpart M—Records ................................................. Clause 4. Quality Management System ................... Differences addressed in 820.35. 

Subpart N—Servicing ................................................ Clause 7. Product Realization .................................. Differences addressed in 820.35. 

Subpart O—Statistical Techniques ........................... Clause 7. Product Realization, Clause 8. Measurement, Analysis, and Improvement.Requirements substantively similar. 

1This table is not intended to be a requirement-by-requirement analysis, but a higher-level mapping of the totality of the subparts and clauses 

of the standard and the QS regulation for reference purposes only. 2 It’s important to note that while there are differences specifically identified in subpart D, document requirements exist in most subparts and 

clauses of the standard and the QS Regulation. 

A. Scope (Proposed § 820.1) 

FDA is not proposing to modify 

which establishments or products are 

subject to part 820. As before, the 

requirements would apply to 

manufacturers of finished devices; 

however, FDA notes that the legal 

authority exists to cover manufacturers 

of components or parts of finished 

devices under this regulation should the 

need arise (see 61 FR 52602 at 52606). 

The proposed modifications to the 

scope of the requirements are nonsubstantive, and include the following: 

1. Clarify that conflicting regulations 

that are more specific are controlling 

only to the extent of the conflict. 

The current § 820.1(b) states that 

when there is a conflict between 

regulations in part 820 and a 

specifically applicable regulation 

located in chapter I of title 21 of the 

CFR, the regulations that specifically 

apply to the device in question 

supersede other generally applicable 

requirements. A reader might interpret 

this provision to mean that the 

specifically applicable regulation 

renders the rest of the part 820 

regulation completely inapplicable. The 

proposed amendment is intended to 

clarify that the generally applicable part 

820 regulations apply to the extent they 

do not otherwise conflict with the 

specifically applicable regulation. 

Moreover, to the extent that any clauses 

of ISO 13485 conflict with any 

provisions of the FD&C Act and/or its 

implementing regulations, the FD&C Act 

and/or its implementing regulations will 

control. 

2. Rearrange some of the content and 

add paragraph breaks for clarity and 

improved flow, for example, separating 

requirements for manufacturers of 

components or parts into a paragraph 

different from the one describing 

manufacturers of finished devices. 

3. Remove the paragraph listing 

authority because the CFR already lists 

the legal authority for the regulation as 

a separate entry. 

4. Relocate the enforcement provision 

to a new separate paragraph in § 820.10. 

B. Definitions (Proposed § 820.3) 

Definitions of key terms related to 

quality management systems appear in 

the current § 820.3 and in Clause 3 of 

ISO 13485. We have reviewed the 

definitions in ISO 13485 to determine 

their suitability for FDA’s purposes. We 

find that most of the definitions in 

Clause 3 are acceptable; thus, unless 

identified in this section, we are not 

proposing any modifications to the 

terms and definitions in Clause 3 and 

are proposing to remove the correlating 

terms and definitions from the current 

part 820. In some cases, however, the 

current § 820.3 definitions include 

terms that ISO 13485 does not and vice 

versa. Further, there are some 

definitions in ISO 13485 that do not 

align with requirements in the FD&C 

Act and its implementing regulations. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10125 

To account for these differences and 

ensure consistency with such law and 

regulations, we are proposing to retain 

and/or revise certain definitions that are 

in the current part 820. We are also 

proposing to withdraw certain terms 

and definitions from the current part 

820 that do not have a corollary in ISO 

13485 because they are not needed to 

understand and implement the 

proposed part 820. Among the 

definitions being withdrawn from the 

current part 820 is the term ‘‘establish’’. 

Though the term establish is not defined 

in the ISO standard, section 0.2 states 

that when a requirement is required to 

be ‘‘documented’’, it is also required to 

be established, implemented, and 

maintained. We believe the clarification 

of this concept within the standard is 

sufficient to convey the current 

requirement for manufacturers to 

establish and maintain the regulatory 

requirements of a QMS. 

1. Terms that do not appear in ISO 

13485 but that are necessary for the 

purposes of part 820 (terms additional 

to ISO 13485) (Proposed § 820.3(a)). 

For the terms that do not appear in 

ISO 13485, but are necessary to ensure 

alignment with the FD&C Act and its 

implementing regulations, we are 

proposing to retain the definitions of 

such terms with minor revisions, as 

indicated below. 

We are proposing to retain the 

definition of Act (see § 820.3(a)) in 

current part 820, except we propose to 

expand the term to more precisely 

reflect the specific act to which the 

definition refers because FDA has the 

authority to promulgate regulations 

under other acts. The addition of 

‘‘Federal Food, Drug, and Cosmetic’’ to 

this term will help avoid potential 

ambiguity if we amend part 820 in the 

future under a different authority. 

We are also proposing to replace the 

term ‘‘management with executive 

responsibility’’ (see § 820.3(n)) in the 

current part 820 with the term ‘‘top 

management’’, which is used in ISO 

13485, but is defined in ‘‘Quality 

Management Systems—Fundamentals 

and Vocabulary,’’ ISO 9000:2015 (ISO 

9000) (Ref. 10). We propose to 

accomplish this by revising the name of 

the term to ‘‘top management’’ but 

retaining the definition in the current 

part 820. This will maintain the 

principle and requirement that the most 

senior employees of a manufacturer are 

responsible for establishing and making 

changes to the quality policy and 

ensuring the manufacturer follows the 

policy. FDA expects medical device 

manufacturers, led by top management, 

to embrace a culture of quality as a key 

component in ensuring safe and 

effective medical devices that otherwise 

comply with the FD&C Act. A culture of 

quality meets regulatory requirements 

through a set of behaviors, attitudes, 

activities, and processes. Top 

management ensures that applicable 

regulatory requirements are met through 

the integration of QS processes. 

We are retaining the majority of the 

definition of ‘‘rework’’; however, we are 

proposing to remove the term ‘‘device 

master record (DMR)’’ (§ 820.3(j)) from 

the regulation. The device master record 

is not a term used in ISO 13485 and so 

this definition does not need to be 

retained. FDA believes the concept of a 

DMR is adequately covered under the 

requirements for a medical device file 

under Clause 4.2.3 of ISO 13485. We are 

retaining the definition of ‘‘process 

validation’’ (§ 820.3(z)(1)) and clarifying 

the concept. FDA recognizes the terms 

‘‘process validation’’ and ‘‘validation of 

processes’’, the term used in ISO 13485, 

as synonymous. We are also proposing 

to include a definition for the term 

‘‘customer’’, as it is important for 

interpretation of the proposed rule. 

Although FDA historically has not used 

the term ‘‘customer’’, we find it is a 

useful term and can encompass many 

types of individuals and organizations 

throughout the device manufacturing 

process, such as component 

manufacturers, contract manufacturers, 

and end users. Requirements related to 

customers are generally consistent with 

the overall intent and purposes behind 

FDA’s regulation of device QMSs, 

which is to assure that finished devices 

will be safe and effective and otherwise 

in compliance with the FD&C Act. 

When considering the requirements 

related to customer property in ISO 

7.5.10, FDA expects that manufacturers 

comply with this provision to the extent 

necessary to assure the safety and 

effectiveness of the devices being 

manufactured. For example, a 

manufacturer is expected to ensure that 

the integrity of a component provided 

by a contract manufacturer is not 

compromised before it is incorporated 

into the device being manufactured. To 

the extent any customer property 

requirements may be interpreted to go 

beyond the safety and effectiveness of 

the devices being manufactured, FDA 

does not intend to enforce this provision 

for such activities. 

We are retaining without change the 

terms and definitions for ‘‘component’’ 

(§ 820.3(c)); ‘‘finished device’’ 

(§ 820.3(l)); ‘‘human cell, tissue, or 

cellular or tissue-based product (HCT/P) 

regulated as a device’’ (820.3(bb)); 

‘‘design validation’’ (§ 820.3(z)(2)); 

‘‘remanufacturer’’ (§ 820.3(w)); 

‘‘nonconformity’’ (§ 820.3(q)); and 

‘‘verification’’ (820.3(aa)) because these 

terms are necessary for implementing 

part 820. 

2. Terms that are defined in ISO 

13485, which we propose not to 

incorporate and are proposing 

definitions that supersede the definition 

of the similar term in the standard 

(Proposed § 820.3(b)). 

There are a number of terms and 

definitions in ISO 13485 that would 

create inconsistencies with the FD&C 

Act and its implementing regulations. 

FDA cannot incorporate any definitions 

of terms that are inconsistent with how 

the FD&C Act defines such terms 

because FDA cannot, nor does it seek to, 

amend its statutory definitions by 

rulemaking. As such, we clarify that the 

definitions of terms in section 201 of the 

FD&C Act (21 U.S.C. 321) supersede the 

definitions in ISO 13485. In particular, 

the definitions of ‘‘device’’ and 

‘‘labeling’’ in sections 201(h) and (m) of 

the FD&C Act, respectively, supersede 

the correlating definitions for ‘‘medical 

device’’ and ‘‘labelling’’ in ISO 13485. 

In addition, we are proposing to retain 

the definition of ‘‘manufacturer’’ 

(§ 820.3(o)) and retain with modification 

the definition of ‘‘product’’ (§ 820.3(r)) 

from the current part 820 because the 

ISO 13485 definitions of these terms do 

not align with the established range of 

these terms by FDA. The definitions in 

proposed part 820 would supersede that 

of the correlating term in ISO 13485. 

With regards to the definition of 

‘‘manufacturer’’, we are proposing to 

retain our current definition because it 

is more comprehensive than the 

definition in ISO 13485. For example, 

FDA’s definition contains a list of 

functions that when performed meet the 

definition of manufacturer. The 

comparable ISO 13485 definition does 

not include this level of detail in its 

definition. This definition is expanded 

upon in the notes to the ISO definition, 

which are guidance—not requirements. 

By explicitly including the functions 

that a manufacturer performs in the 

proposed definition, the Agency intends 

to maintain its original interpretation of 

this term and to clarify the functions 

that continue to be subject to the 

requirements of part 820. 

A similar logic has been applied to 

the definition of ‘‘product’’. FDA’s 

definition of product includes a list of 

items considered to be ‘‘product’’ for the 

purposes of part 820 that is not included 

in the definition in ISO 13485, but some 

of which are included in the notes to the 

ISO definition. 

Additionally, we note that consistent 

with the clarification in clause 0.2, 

which specifies that ‘‘when the term 

‘product’ is used, it can also mean 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10126 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

‘service’,’’ for the requirements of clause 

7.4 Purchasing we expect that when 

ensuring purchased products conform to 

requirements, oversight for purchased 

services are also included. 

C. Incorporation by Reference (Proposed 

§ 820.7) 

As stated above, FDA is proposing to 

incorporate by reference the 

International Standard, ISO 13485:2016 

Medical devices—Quality management 

systems—Requirements for regulatory 

purposes, Third Edition 2016–03–01. 

ISO 13485 provides a comprehensive 

approach to establish a quality 

management system for medical 

devices. If this proposed rule is 

finalized, it will provide most of the 

CGMP requirements for devices. We 

note that the definitions in ISO 9000 

apply to ISO 13485; however, to the 

extent that there is any conflict between 

ISO 9000 and the FD&C Act and its 

implementing regulations, the FD&C Act 

and its implementing regulations would 

control. 

While we recognize that adopting ISO 

13485 could seem like a significant 

change, the current part 820 and ISO 

13485 are substantially similar, and this 

effort promotes international 

harmonization. The substance of the 

ISO 13485 requirements and the 

activities and actions required for 

compliance are primarily the same as 

under the current part 820. ISO 13485 

has a greater emphasis on risk 

management activities and risk-based 

decision making than the current part 

820. Risk management for device 

manufacturers is the essential 

systematic practice of identifying, 

analyzing, evaluating, controlling, and 

monitoring risk throughout the product 

lifecycle to ensure that the devices they 

manufacture are safe and effective. The 

current part 820 explicitly addresses 

risk management activities only in the 

risk analysis requirement within design 

validation in § 820.30(g); whereas, risk 

management is more broadly integrated 

in ISO 13485. FDA, however, has 

expected that manufacturers, led by top 

management, integrate risk management 

activities throughout their QMS and 

across the total product lifecycle. FDA 

discussed risk management and riskbased decision making in several 

sections of the 1996 Final Rule 

establishing the current QS 

requirements. For example, while not 

specified in the requirements for 

Corrective and Preventive Action 

(§ 820.100), FDA states that it ‘‘expect[s] 

the manufacturer to develop procedures 

for assessing the risk, the actions that 

need to be taken for different levels of 

risk, and how to correct or prevent the 

problem from recurring, depending on 

that risk assessment’’ (61 FR 52602 at 

52634). Additionally, FDA states that 

‘‘[w]hen conducting a risk analysis, 

manufacturers are expected to identify 

possible hazards associated with the 

design in both normal and fault 

conditions. The risks associated with 

the hazards, including those resulting 

from user error, should then be 

calculated in both normal and fault 

conditions. If any risk is judged 

unacceptable, it should be reduced to 

acceptable levels by the appropriate 

means’’ (61 FR 52602 at 52620). FDA 

has, therefore, expected risk 

management throughout a QMS and the 

total product lifecycle. 

Nonetheless, although the integration 

of risk management principles 

throughout ISO 13485 does not 

represent a shift in philosophy, the 

explicit integration of risk management 

throughout the clauses of ISO 13485 

more explicitly establishes a 

requirement for risk management to 

occur throughout a QMS and should 

help industry develop more effective 

total product life-cycle risk management 

systems. Effective risk management 

systems provide the framework for 

sound decision making within a QMS 

and provide assurance that the devices 

will be safe and effective (see section 

520(f) of the FD&C Act). 

D. Proposed Requirement for a Quality 

Management System (Proposed 

§ 820.10) 

The current § 820.5 requires that 

manufacturers establish and maintain a 

quality management system that meets 

the requirements of part 820. We 

propose to relocate this requirement 

within the codified and to revise this 

provision to require that a quality 

management system that complies with 

ISO 13485, as modified by the proposed 

part 820, be documented. These 

requirements will serve as the minimum 

requirements for establishing a QMS 

that complies with the final version of 

this proposed rule. In general, when ISO 

13485 refers to documenting evidence 

we recommend that manufacturers 

record quantitative data, as appropriate, 

because such information will assist 

manufacturers in monitoring the 

performance of their processes and 

effectiveness of their process controls. 

In addition, there are many clauses 

throughout ISO 13485 that refer to 

‘‘applicable regulatory requirements.’’ 

We propose to include the FDA 

requirements that must be completed 

when the listed term or clause is used, 

in order to assist manufacturers in 

understanding how ISO 13485 relates to 

other regulatory requirements for 

devices. We are only proposing to 

identify certain instances of the phrase 

‘‘applicable regulatory requirements’’ 

and therefore the proposed list is not 

intended to be comprehensive. 

Regulated manufacturers are responsible 

for identifying and meeting all 

applicable requirements, even if such 

requirements are not specifically called 

out in the proposed § 820.10. 

We also propose to clarify that Clause 

7.3 Design and Development applies 

only to the manufacturers of the class I 

devices that are listed in this provision 

in addition to all manufacturers of class 

II and III devices. This retains the scope 

of current § 820.30(a). We are not 

proposing to modify which devices are 

subject to these requirements and are 

only revising this provision to reflect 

the location of similar requirements in 

ISO 13485. We also note that this is 

consistent with clause 1 of ISO 13485, 

which recognizes that there may be 

exclusions by the regulatory authority 

from the Design and Development 

requirement and directs the 

manufacturer to document such in its 

justification for exclusion. 

Finally, we are proposing to add a 

requirement to ensure that devices that 

support or sustain life, the failure of 

which to perform when properly used 

in accordance with instructions for use 

provided in the labeling can be 

reasonably expected to result in a 

significant injury, comply with the 

traceability requirements set forth in in 

Clause 7.5.9.2 for implantable medical 

devices. Such products currently are 

subject to similar requirements in 

§ 820.65 for traceability; however, in 

ISO 13485 only implantable devices are 

subject to this requirement. 

E. Proposed Clarification of Concepts 

(Proposed § 820.15) 

We are including clarifications for 

three concepts to explain how these 

concepts in ISO 13485 relate to our 

statutory and regulatory framework for 

medical devices. 

Organization. ISO 13485 uses the 

term ‘‘organization’’ to describe the 

entity who is creating a QMS that 

conforms to the requirements in ISO 

13485. Instead, we propose to clarify the 

term ‘‘organization’’ to also include the 

meaning of the term ‘‘manufacturer’’ as 

it is defined in proposed § 820.3. 

Safety and performance. ISO 13485 

often refers to ‘‘safety and performance’’ 

as a standard to measure medical 

devices. We propose that where the 

standard uses ‘‘safety and performance,’’ 

readers shall construe that phrase to 

mean the same as ‘‘safety and 

effectiveness’’ in section 520(f) of the 

FD&C Act. We understand that some 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10127 

people could disagree about how the 

two standards compare, whether one is 

more stringent than the other, or even 

equivalent. In proposing this 

clarification, we do not intend to take a 

position on the matter of comparison. 

Instead, we propose this clarification to 

avoid confusion and ensure that 

implementation of a QMS is aligned 

with the standard of safety and 

effectiveness in section 520(f) of the 

FD&C Act and otherwise established for 

devices in FD&C Act. 

Validation of processes. ISO 13485 

uses the term ‘‘validation of processes’’ 

and does not contain its own definition 

of the term. We propose to clarify the 

term ‘‘validation of processes’’ as used 

in ISO 13485 to refer to ‘‘process 

validation,’’ as that term is defined in 

part 820. We are retaining the definition 

of process validation (§ 820.3(z)(1)) 

because ISO 13485 does not define 

‘‘validation of processes,’’ but the use is 

the same as that expected for process 

validation under part 820. This will also 

allow for alignment between ISO 13485 

and other requirements in the FD&C Act 

and its implementing regulations. 

F. Proposed Supplementary Provisions 

(Proposed Subpart B) 

As stated above, we are proposing 

additional requirements to ensure 

consistency and alignment with other 

requirements in the FD&C Act and its 

implementing regulations. FDA 

considers the following requirements 

necessary for implementation of a QMS 

that is consistent with applicable 

requirements but are not specified in 

ISO 13485. These requirements include 

control of records and device labeling 

and packaging controls. 

FDA notes that the current part 820 

contains requirements for record types 

that are not specifically identified in 

ISO 13485, such as, quality system 

record, device master record, design 

history file, and device history record. 

We are not proposing to retain separate 

requirements for these record types as 

we believe the elements that comprise 

those records are largely required to be 

documented by other ISO 13485 

Clauses, such as Clause 4.2 and its 

subclauses. 

1. Proposal for Control of Records 

(Proposed § 820.35) 

We propose additional requirements 

to help ensure that records are 

established and maintained in a manner 

that is useful to FDA and manufacturers. 

First, we propose to include signature 

and date requirements for records 

subject to Clause 4.2.5 of ISO 13485. 

Such requirements provide clarity on 

the information FDA needs to ensure 

validity of records. Records are not 

necessarily limited to hardcopy 

documents that are physically signed. 

Manufacturers can choose to develop 

electronic records and electronic 

methods for signing and dating such 

records, if that best suits their business 

practices. Our focus is on whether the 

substance of the requirements is met 

and not the physicality of the record or 

signature methodology. Second, FDA is 

proposing specific requirements to 

ensure that the information required by 

part 803 (21 CFR part 803), Medical 

Device Reporting, is captured on certain 

records of complaints and servicing 

activities. Third, we propose to require 

that firms document the Unique Device 

Identification (UDI) for each medical 

device or batch of medical devices in 

accordance with 21 CFR part 830 in its 

records. Last, we are proposing to retain 

the clarification from the current part 

820 (§ 820.180) about confidentiality of 

records FDA receives. This reminds 

firms that FDA protects such records in 

accordance with 21 CFR part 20. If this 

rule is finalized as proposed, 

manufacturers must meet the 

requirements in ISO 13485 Clause 4.2.5 

and also meet the requirements of the 

eventual § 820.35. 

We also note that ISO 13485 Clause 

4.2.5 requires that records be ‘‘readily 

identifiable and retrievable.’’ FDA 

considers this phrase to be substantially 

similar to the requirement in current 

part 820 (§ 820.180) that records be 

‘‘reasonably accessible’’ and ‘‘readily 

available.’’ In the 1996 Final Rule, the 

Agency explained that ‘‘FDA expects 

that such records will be made available 

during the course of an inspection. If the 

foreign manufacturer maintains records 

at remote locations, such records would 

be expected to be produced by the next 

working day or 2, at the latest. FDA has 

clarified that records can be kept at 

other than the inspected establishment, 

provided that they are made ‘readily 

available’ for review and copying.’’ (61 

FR 52602 at 52637). FDA will consider 

records that a manufacturer makes 

available in accordance with this 

statement to be ‘‘readily identifiable and 

retrievable.’’ 

2. Proposed Controls for Device 

Labeling and Packaging (Proposed 

§ 820.45) 

Each year, device recalls are initiated 

related to product labeling and 

packaging. Clause 7.5.1(e) of ISO 13485 

states that ‘‘defined operations for 

labelling and packaging shall be 

implemented.’’ However, ISO 13485 

fails to provide additional requirements 

for labeling and packaging and does not 

specifically address the inspection of 

labeling by the manufacturer. Therefore, 

FDA proposes to retain requirements 

from the current part 820 that would 

strengthen controls for labeling and 

packaging operations, given that many 

device recalls are related to labeling and 

packaging. FDA believes that these 

provisions will better assure the 

manufacture of safe and effective 

devices. If this rule is finalized as 

proposed, regulated industry must meet 

the requirements in ISO 13485 7.5.1 and 

the proposed § 820.45. 

G. Proposed Conforming Amendments 

We are proposing to amend part 4 to 

reflect the amendments made to part 

820 in incorporating ISO 13485 by 

reference. As explained above, part 4 

provides a streamlined option to 

demonstrate compliance with the 

multiple, applicable sets of CGMP 

requirements for certain combination 

products (i.e., single-entity and copackaged combination products). To do 

so, one option part 4 presents for singleentity and co-packaged combination 

products with device constituent parts 

is to demonstrate compliance with the 

requirements of one other applicable set 

of requirements along with specified 

provisions of part 820 (rather than all 

provisions). We are not proposing to 

change the underlying activities 

required of manufacturers that pursue 

this streamlined option. Instead, we are 

proposing conforming amendments to 

the part 4 references to the 

corresponding clauses in ISO 13485. To 

that end, we are taking comment on the 

proposed conforming amendments and 

whether additional changes are 

necessary to assure compliance with 

part 4. The QS requirements outlined in 

part 4 are not fundamentally different 

than the corresponding requirements in 

ISO 13485. 

VI. Proposed Effective Date and 

Implementation Strategy 

FDA proposes that any final rule 

based on this proposal become effective 

1 year after the date of publication of the 

final rule in the Federal Register. This 

approach is intended to provide 

adequate time for manufacturers to 

make any changes necessary to comply 

with the requirements of ISO 13485. We 

welcome comment on this approach. 

Although this rule does not impact 

FDA’s authority to conduct inspections 

under section 704 of the FD&C Act, FDA 

intends to replace its current inspection 

approach for medical devices, the 

Quality System Inspection Technique 

(QSIT), with an inspection approach 

that will be consistent with the 

requirements of the proposed part 820 

as finalized. Similar to the current QSIT 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10128 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

inspection approach, these inspections 

would involve the collection of 

information to support observations 

noted during the inspection and those 

included on a Form FDA 483, as 

appropriate and necessary. FDA 

inspections will not result in the 

issuance of certificates of conformance 

to ISO 13485, nor is FDA developing a 

certification program for ISO 13485. In 

addition, manufacturers with a 

certificate of conformance to ISO 13485 

are not exempt from FDA inspections. If this rule is finalized, FDA intends 

to engage in a variety of implementation 

activities including, among other 

activities, updating information 

technology systems, training of 

personnel, finalizing the inspection 

approach, and revising relevant 

regulations and other documents 

impacted by this rulemaking. 

VII. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct us to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). We 

believe that this proposed rule is an 

economically significant regulatory 

action as defined by Executive Order 

12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because of the burden of the proposed 

rule on very small medical device 

establishment (as defined in the 

analysis), we propose to certify that the 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $158 million, 

using the most current (2020) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

We estimated the benefits in terms of 

cost savings. These cost savings are 

primarily due to the potential reduction 

in redundant effort in compliance of 

similar regulations and standards by 

medical device establishments. The 

annualized costs savings of medical 

device establishments are estimated at 

approximately $533 million at a 7 

percent discount rate, and 

approximately $439 million at a 3 

percent discount rate. In addition, if 

finalized, we believe that there will be 

added benefits through quicker access to 

newly developed medical devices for 

patients, leading to improvement of life 

quality for the consumers. The cost of 

the proposed rule primarily consists of 

a one-time initial expenditure for 

updating systems and protocols, and 

training personnel for medical device 

establishments, which currently do not 

comply with ISO 13485. The cost 

estimate for these establishments is 

annualized at $7.0 million at a 7 percent 

discount rate, and approximately $5.8 

million at a 3 percent discount rate. 

TABLE 2—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

[Millions $] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 1

Annualized Monetized $M/year ........................... $533 

439 

$267 

220 

$1,332 

1,097 

2020 

2020 

7 

3 

10 

10 

Benefit are cost savings. 

Benefit are cost savings. 

Annualized Quantified .......................................... .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

Qualitative ............................................................ .................. .................. .................. .................. .................. ..................

Costs: 

Annualized Monetized $M/year ........................... 6.96 

5.73 

6.96 

5.73 

6.96 

5.73 

2020 

2020 

7 

3 

10 

10 

Annualized Quantified .......................................... .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

Qualitative ............................................................ .................. .................. .................. .................. .................. ..................

Transfers: 

Federal Annualized Monetized $M/year .............. .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

From/To ............................................................... From: To: 

Other Annualized Monetized $M/year ................. .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

From/To ............................................................... From: To: 

Effects: 

State, Local or Tribal Government: 

Small Business: 

Wages: 

Growth: 

1Estimated benefits are in terms of cost savings for medical device establishments that conform to the current part 820. Other benefits that are not quantified potentially include quicker delivery and more efficient access to necessary devices for patients, leading to improvement of quality of life for consumers. 

Note: All figures are in millions of dollars. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10129 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule (Ref. 11) and at https://

www.fda.gov/about-fda/reports/ 

economic-impact-analyses-fdaregulations. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(j) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by the OMB under 

the PRA (44 U.S.C. 3501–3521). A 

description of these provisions is given 

in the Description section with an 

estimate of the annual recordkeeping 

burden. Included in the estimate is the 

time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. 

FDA invites comments on these 

topics: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Medical Devices; Quality 

Management System; OMB Control 

Number 0910–0073—Revision. 

Description: FDA is proposing to 

revise its device CGMP requirements as 

set forth in the QS regulation, codified 

in part 820. Through this proposed 

rulemaking, FDA intends to converge its 

requirements with QMS requirements 

used by other regulatory authorities. 

FDA seeks to accomplish this primarily 

by incorporating by ISO 13485. This 

rule, if finalized, would harmonize QMS 

requirements for devices with 

requirements used by other regulatory 

authorities. 

Description of Respondents: 

Respondents to this information 

collection are any manufacturers 

engaged in the design, manufacture, 

packaging, labeling, storage, installation, 

or servicing of a finished device, 

including, but not limited to, 

organizations that perform the functions 

of contract sterilization, installation, 

relabeling, remanufacturing, repacking, 

or specification development, as well as 

initial distributors of foreign entities 

that perform these functions. 

Manufacturers of components or parts 

of finished devices may voluntarily use 

appropriate provisions of the proposed 

regulation as guidance. 

Respondents are also manufacturers 

of human cells, tissues, and cellular and 

tissue-based products (HCT/Ps), as 

defined in 21 CFR 1271.3(d), that are 

devices. 

We estimate the burden of this 

collection of information as follows: 

TABLE 3—ESTIMATED ONE-TIME RECORDKEEPING BURDEN

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total records 

Average 

burden per 

recordkeeping 

Total hours Total capital 

costs 

Learn the rule—one-time burden ............. 20,346 1 20,346 2.6 52,900 $7,600,000 

Initial one-time burden for those respondents whose processes do not already 

comply with ISO 13485 ........................ 4,445 1 4,445 64 284,480 43,000,000 

Total .................................................. ........................ ........................ ........................ ........................ 337,380 50,600,000 

The currently approved number of 

respondents to the collection is 27,074; 

however we expect nominal 

fluctuations in the number of registered 

medical device facilities and have 

reduced that number to 20,346 based on 

a current review of data and to be 

consistent with the Preliminary 

Regulatory Impact Analysis for this 

proposed rule (see Ref. 11). 

All medical device establishments 

that will be covered under the 

rulemaking undergo a one-time burden 

to learn the rulemaking. We model the 

one-time learning cost as the time 

required by medical device 

establishments’ regulatory affairs expert 

to access and read the proposed rule, 

approximately 2.6 hours (rounded). The 

average total access and learning cost for 

all affected entities is approximately 

$7,600,000 (see Ref. 11). 

In addition to learning the rule 

requirements, medical device 

establishments that are not in 

compliance with ISO 13485 when the 

rulemaking is implemented would incur 

one-time initial costs related to training 

of a regulatory compliance expert, 

updating information technology, and 

updating documents related to policy 

and procedures. The additional 

estimated cost burden for medical 

device establishments that are not in 

compliance with ISO 13485 when the 

rulemaking is implemented is 

approximately $43,000,000 (see Ref. 11). 

The estimated hour burden of these 

additional one-time activities is 

included under ‘‘Initial one-time burden 

for those respondents whose processes 

do not already comply with ISO 13485’’ 

in table 3. In the Preliminary Regulatory 

Impact Analysis for this rulemaking, we 

estimate there are 4,445 respondents 

that do not currently comply with ISO 

13485 and that the average burden per 

recordkeeping is approximately 64 

hours (Ref. 11). Because we do not have 

robust data on the number of firms that 

currently comply with ISO 13485, we 

are using very small domestic medical 

device manufacturing establishments to 

represent those who will proportionally 

bear a greater burden of one-time costs 

by the proposed rule. As such, for this 

analysis, and as discussed in the 

Preliminary Regulatory Impact Analysis, 

we assume that very small medical 

device manufacturing establishments 

currently do not sell their products 

abroad and do not comply with ISO 

13485 (Ref. 11). 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10130 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

Activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Quality Management System (proposed § 820.10 and ISO 

13485) .............................................................................. 20,346 1 20,346 348 7,080,408 

Control of records (proposed § 820.35) ............................... 20,346 1 20,346 2 40,692 

Total .............................................................................. ........................ ........................ ........................ ........................ 7,121,100 

1There are no capital costs or operating and maintenance costs associated with this annual collection of information. 

2 Numbers have been rounded. 

The current burden associated with 

recordkeeping requirements in part 820 

is 9,021,752 hours annually. We assume 

a commensurate level of burden for the 

proposed recordkeeping activities (350 

hours for the Average Burden per 

Recordkeeping). 

As mentioned previously in this 

section, we expect nominal fluctuations 

in the number of registered medical 

device facilities and have reduced that 

number from 27,074 to 20,346 based on 

a current review of data and to be 

consistent with the Preliminary 

Regulatory Impact Analysis for this 

proposed rule (see Ref. 11). This 

adjustment results in a reduction of 

1,900,652 total hours annually. 

Quality Management System 

(proposed § 820.10 and ISO 13485): 

Under proposed § 820.10, an 

organization subject to proposed part 

820 must document a QMS that 

complies with the requirements of ISO 

13485, as incorporated by reference in 

proposed § 820.7, and proposed part 

820. 

Under proposed § 820.10(c), 

manufacturers of class II, class III, and 

certain class I devices, as listed in 

proposed § 820.10(c)(ii), must comply 

with the requirements in Design and 

Development, Clause 7.3 and its 

Subclauses in ISO 13485. This 

amendment does not substantively 

change the current recordkeeping 

requirement. 

Under proposed § 820.10(d), 

manufacturers of devices that support or 

sustain life, the failure of which to 

perform when properly used in 

accordance with instructions for use 

provided in the labeling can be 

reasonably expected to result in a 

significant injury, must comply with the 

requirements in Traceability for 

Implantable Devices, Clause 7.5.9.2 in 

ISO 13485, in addition to all other 

requirements in this part, as 

appropriate. This amendment does not 

substantively change the current 

recordkeeping requirement. 

Control of records (proposed 

§ 820.35): In addition to the 

requirements of Clause 4.2.5 in ISO 

13485, Control of Records, the 

manufacturer must obtain the signature 

for each individual who approved or reapproved the record, and the date of 

such approval, on that record and 

include the information in certain 

records as listed in proposed § 820.35. 

In addition to Clause 8.2.2 in ISO 

13485, Complaint Handling, the 

manufacturer must record the listed 

information, at a minimum, for 

complaints that must be reported to 

FDA under part 803, complaints that a 

manufacturer determines must be 

investigated, and complaints that the 

manufacturer investigated regardless of 

those requirements. The reporting 

requirements of part 803 are approved 

under OMB control number 0910–0437. 

Estimated burden for the recordkeeping 

requirement in proposed § 820.35(a) is 

included as part of the estimate for 

‘‘Control of records (proposed § 820.35)’’ 

in table 4. 

In adhering to Clause 7.5.4 in ISO 

13485, Servicing Activities, the 

manufacturer must record the 

information listed in proposed 

§ 820.35(b), at a minimum, for servicing 

activities. 

Under proposed § 820.35(c), in 

addition to the requirements of Clauses 

7.5.1, 7.5.8, and 7.5.9 of ISO 13485, the 

UDI must be recorded for each medical 

device or batch of medical devices. The 

estimated recordkeeping burden 

associated with UDI is included as part 

of the estimate for ‘‘Control of records 

(proposed § 820.35)’’ in table 4. 

Because the records required by 

proposed § 820.35 should be readily 

available to the respondents, we 

estimate the average burden per 

response for proposed § 820.35 to be no 

more than 2 hours. This estimate is in 

addition to the requirements of the 

applicable ISO 13485 Clauses, the 

burden for which is included under 

‘‘Quality Management System (proposed 

§ 820.10 and ISO 13485)’’ in table 4. 

Device labeling and packaging 

controls (proposed § 820.45): In addition 

to the requirements of Clause 7.5.1 of 

ISO 13485, Control of production and 

service provision, manufacturers must 

ensure labeling and packaging has been 

examined for accuracy prior to release 

or storage (§ 820.45(a)), the release of the 

labeling for use must be documented in 

accordance with Clause 4.2.5 of ISO 

13485 (§ 820.45(b)), and results of the 

labeling inspection in proposed 

§ 820.45(c) must be documented in 

accordance with Clause 4.2.5 of ISO 

13485. The estimated recordkeeping 

burden for ISO 13485, Clause 4.2.5, is 

part of the estimate for ‘‘Quality 

Management System (proposed § 820.10 

and ISO 13485)’’ in table 4. There is no 

additional hour burden associated with 

proposed § 820.45. 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be submitted through https:// 

www.reginfo.gov/public/do/PRAMain 

(see ADDRESSES). All comments should 

be identified with the title of the 

information collection. 

In compliance with the PRA (44 

U.S.C. 3501, et seq.), we have submitted 

the information collection provisions of 

this proposed rule to OMB for review. 

These information collection 

requirements will not be effective until 

FDA publishes a final rule, OMB 

approves the information collection 

requirements, and the rule goes into 

effect. FDA will announce OMB 

approval of these requirements in the 

Federal Register. 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

Order and, consequently, a federalism 

summary impact statement is not 

required. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10131 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

XII. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

* 1. ISO 13485:2016, ‘‘Medical devices— 

Quality management systems— 

Requirements for regulatory purposes,’’ 

Third Edition, March 1, 2016. 

* 2. FDA, ‘‘Regulations Establishing Good 

Manufacturing Practices for the 

Manufacture, Packing, Storage, and 

Installation of Medical Devices.’’ Federal 

Register, 43: 31508–31532, July 21, 1978. 

3. ISO 13485:1996, ‘‘Quality systems— 

Medical devices—Particular 

requirements for the application of ISO 

9001,’’ December 1996 (withdrawn). 

(Referenced at: https://www.iso.org/ 

standard/22098.html.) 

4. ISO 9001:1994, ‘‘Quality Systems—Model 

for Quality Assurance in Design, 

Development, Production, Installation, 

and Servicing,’’ June 1994 (withdrawn). 

(Referenced at: https://www.iso.org/ 

standard/25946.html.) 

* 5. FDA, ‘‘Medical Device Single Audit 

Program (MDSAP).’’ (Available at: 

https://www.fda.gov/medical-devices/ 

cdrh-international-programs/medicaldevice-single-audit-program-mdsap.) 

6. Global Harmonization Task Force. 

Guidance document, ‘‘Implementation of 

Risk Management Principles and 

Activities Within a Quality Management 

System,’’ May 20, 2005. (Available at: 

http://www.imdrf.org/docs/ghtf/final/ 

sg3/technical-docs/ghtf-sg3-n15r8-riskmanagement-principles-qms050520.pdf.) 

7. ISO 14971, ‘‘Medical Devices— 

Application of Risk Management to 

Medical Devices.’’ (Available at: https:// 

www.iso.org/standard/72704.html.) 

* 8. ‘‘Guidance for Industry, Third Parties 

and Food and Drug Administration Staff: 

Medical Device ISO 13485:2003 

Voluntary Audit Report Submission Pilot 

Program’’ effective June 5, 2012. Federal 

Register, March 19, 2012 (Available at: 

https://www.federalregister.gov/citation/ 

77-FR-16036). 

9. International Medical Device Regulators 

Forum, http://www.imdrf.org/. 

10. International Standard, ISO 9000 

‘‘Quality Management Systems— 

Fundamentals and Vocabulary,’’ ISO 

9000:2015. (Available at: ISO 

9000:2015(en), Quality management 

systems—Fundamentals and 

vocabulary.) 

* 11. ‘‘Preliminary Regulatory Impact 

Analysis, Initial Regulatory Flexibility 

Analysis, and Unfunded Mandates 

Reform Act Analysis; Medical Devices; 

Quality System Regulation 

Amendments.’’ (Available at: https://

www.fda.gov/about-fda/reports/ 

economic-impact-analyses-fdaregulations.) 

List of Subjects 

21 CFR Part 4 

Biologics, Drugs, Human cells and 

tissue-based products, Incorporation by 

reference, Medical devices. 

21 CFR Part 820 

Incorporation by reference, Medical 

devices, Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR parts 4 and 820 be amended as 

follows: 

PART 4—REGULATION OF 

COMBINATION PRODUCTS 

■ 1. The authority citation for part 4 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360b–360f, 360h–360j, 360l, 

360hh–360ss, 360aaa–360bbb, 371(a), 372– 

374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 

263a, 264, 271. 

■ 2. In § 4.2, 

■ a. Revise the definition of ‘‘Device’’; 

and 

■ b. Remove the definition of ‘‘QS 

regulation’’, and add in its place a 

definition for ‘‘QMSR for devices’’. 

The revision and addition read as 

follows: 

§ 4.2 How does FDA define key terms and 

phrases in this subpart? 

* * * * * 

Device has the meaning set forth in 

§ 3.2(f) of this chapter. A device that is 

a constituent part of a combination 

product is considered a finished device 

within the meaning of the Quality 

Management System Regulation 

(QMSR). 

* * * * * 

QMSR for devices refers to the 

requirements under part 820 of this 

chapter. 

* * * * * 

■ 3. In § 4.4, revise paragraph (b)(1) and 

the introductory text to paragraph (b)(2) 

and add paragraph (f) to read as follows: 

§ 4.4 How can I comply with these current 

good manufacturing practice requirements 

for a co-packaged or single-entity 

combination product? 

* * * * * 

(b) * * * 

(1) If the combination product 

includes a device constituent part and a 

drug constituent part, and the current 

good manufacturing practice operating 

system has been shown to comply with 

the drug CGMPs, the following clauses 

of ISO 13485 within the QMSR 

requirements for devices must also be 

shown to have been satisfied; upon 

demonstration that these requirements 

have been satisfied, no additional 

showing of compliance with respect to 

the QMSR requirements for devices 

need be made: 

(i) Management responsibility. Clause 

4.1, Clause 5 and its subclauses and 

Clause 6.1 of ISO 13485; 

(ii) Design and development. Clause 

7.3 and its subclauses of ISO 13485; 

(iii) Purchasing. Clause 7.4 and its 

subclauses of ISO 13485; 

(iv) Improvement. Clause 8.4, Clause 

8.5 and its subclauses of ISO 13485; 

(v) Installation activities. Clause 7.5.3 

of ISO 13485; and 

(vi) Servicing activities. Clause 7.5.4 

of ISO 13485 and § 820.35(b). 

(2) If the combination product 

includes a device constituent part and a 

drug constituent part, and the current 

good manufacturing practice operating 

system has been shown to comply with 

the QMS requirements for devices, the 

following provisions of the drug CGMPs 

must also be shown to have been 

satisfied; upon demonstration that these 

requirements have been satisfied, no 

additional showing of compliance with 

respect to the drug CGMPs need be 

made: 

* * * * * 

(f) Certain material is incorporated by 

reference into this section with the 

approval of the Director of the Federal 

Register under 5 U.S.C. 552(a) and 1 

CFR part 51. All approved material is 

available for inspection at the Food and 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10132 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

Drug Administration, Dockets 

Management Staff, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 20852, 240– 

402–7500, and at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, email fr.inspection@nara.gov, or 

go to www.archives.gov/federal-register/ 

cfr/ibr-locations.html. It is available 

from the following source(s): 

(1) The International Organization for 

Standardization (ISO), BIBC II, Chemin 

de Blandonnet 8, CP 401, 1214 Vernier, 

Geneva, Switzerland; +41–22–749–01– 

11; customerservice@iso.org, https://

www.iso.org/store.html. 

(i) ISO 13485, ‘‘Medical devices— 

Quality management systems— 

Requirements for regulatory purposes,’’ 

third edition, dated March 2016, 

(ii) [Reserved] 

(2) [Reserved] 

■ 4. Revise part 820 to read as follows: 

PART 820—QUALITY MANAGEMENT 

SYSTEM REGULATION 

Subpart A—General Provisions 

Sec. 

820.1 Scope. 

820.3 Definitions. 

820.5 [Reserved] 

820.7 Incorporation by reference. 

820.10 Requirements for a quality 

management system. 

820.15 Clarification of concepts. 

Subpart B—Supplemental Provisions 

820.20–820.30 [Reserved] 

820.35 Control of records. 

820.40 [Reserved] 

820.45 Device labeling and packaging 

controls. 

Subparts C–O—[Reserved] 

Authority: 21 U.S.C. 351, 352, 360, 360c, 

360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 

381, 383; 42 U.S.C. 216, 262, 263a, 264. 

Subpart A—General Provisions 

§ 820.1 Scope. 

(a) Applicability. Current good 

manufacturing practice (CGMP) 

requirements are set forth in this quality 

management system regulation (QMSR). 

The requirements in this part govern the 

methods used in, and the facilities and 

controls used for, the design, 

manufacture, packaging, labeling, 

storage, installation, and servicing of all 

finished devices intended for human 

use. The requirements in this part are 

intended to assure that finished devices 

will be safe and effective and otherwise 

in compliance with the Federal Food, 

Drug, and Cosmetic Act. Any 

manufacturers engaged in the design, 

manufacture, packaging, labeling, 

storage, installation, or servicing of a 

finished device must establish and 

maintain a quality management system 

that is appropriate for its specific 

device(s). Manufacturers subject to this 

part include, but are not limited to, 

manufacturers that perform the 

functions of contract sterilization, 

installation, relabeling, 

remanufacturing, repacking, or 

specification development, as well as 

initial distributors of foreign entities 

that perform these functions. If a 

manufacturer engages in only some 

operations subject to the requirements 

in this part, and not in others, that 

manufacturer need only comply with 

those requirements applicable to the 

operations in which it is engaged. 

(1) Finished devices. The provisions 

of this part shall apply to any finished 

device, as defined in this part, intended 

for human use, that is manufactured, 

imported, or offered for import in any 

State or Territory of the United States, 

the District of Columbia, or the 

Commonwealth of Puerto Rico. 

(2) Components or parts. The 

provisions of this part do not apply to 

manufacturers of components or parts of 

finished devices, but such 

manufacturers are encouraged to 

consider provisions of this regulation as 

appropriate. 

(3) Blood and blood components. The 

provisions of this part do not apply to 

manufacturers of blood and blood 

components used for transfusion or for 

further manufacturing. Such 

manufacturers are subject to subchapter 

F of this chapter. 

(4) HCT/Ps. The provisions of this 

part apply to manufacturers of human 

cells, tissues, and cellular and tissuebased products (HCT/Ps), as defined in 

§ 1271.3(d) of this chapter, that are 

devices (subject to premarket review or 

notification, or exempt from 

notification, under an application 

submitted under the device provisions 

of the Federal Food, Drug, and Cosmetic 

Act or under a biological product 

license application under section 351 of 

the Public Health Service Act). HCT/Ps 

regulated as devices are also subject to 

the donor-eligibility requirements set 

forth in part 1271, subpart C of this 

chapter and applicable current good 

tissue practice requirements in part 

1271, subpart D of this chapter. In the 

event of a conflict between applicable 

regulations in part 1271 and in other 

parts of this chapter, the regulation 

specifically applicable to the device in 

question shall supersede the more 

general regulation. 

(b) Conflicts with other requirements 

under the Federal Food, Drug, and 

Cosmetic Act. The QMSR for devices in 

this part supplements regulations in 

other parts of this chapter except where 

explicitly stated otherwise. In the event 

of a conflict between applicable 

regulations in this part and in other 

parts of this chapter, the regulations 

specifically applicable to the device in 

question shall supersede the more 

generally applicable regulations to the 

extent they conflict. Moreover, to the 

extent that any clauses of ISO 13485 

(incorporated by reference, see § 820.7) 

conflict with any provisions of the 

Federal Food, Drug, and Cosmetic Act 

and/or its other implementing 

regulations, the Federal Food, Drug, and 

Cosmetic Act and/or its other 

implementing regulations will control. 

(c) Foreign manufacturers. If it 

appears that an owner, operator, or 

agent of any factory, warehouse, or 

establishment who offers devices for 

import into the United States delays, 

denies, or limits an inspection, or 

refuses to permit entry or inspection of 

the foreign facility for the purpose of 

determining compliance with this part, 

or the methods used in, and the 

facilities and controls used for, the 

manufacture, packing, storage, 

installation, processing, or held in such 

factory, warehouse, or establishment 

that are offered for import into the 

United States do not conform to the 

requirements of section 520(f) of the 

Federal Food, Drug, and Cosmetic Act 

and this part, then the devices 

manufactured at that facility are 

adulterated under section 501(h) or (j) of 

the Federal Food, Drug, and Cosmetic 

Act and will be refused admission to the 

United States under section 801(a) of 

the Federal Food, Drug, and Cosmetic 

Act. 

(d) Exemptions or variances. (1) A 

manufacturer subject to any requirement 

under section 520(f)(1) of the Federal 

Food, Drug, and Cosmetic Act, 

including any requirements under this 

part, may petition for an exemption or 

variance from such requirement in 

accordance with section 520(f)(2) of the 

Federal Food, Drug, and Cosmetic Act. 

Petitions for an exemption or variance 

shall be submitted in accordance with 

the procedures set forth in § 10.30 of 

this chapter. 

(2) FDA may initiate and grant a 

variance from any requirement(s) in this 

part when the Agency determines that 

such variance is in the best interest of 

the public health. Such variance will 

remain in effect only so long as there 

remains a public health need for the 

device and the device would not likely 

be made sufficiently available without 

the variance. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10133 

§ 820.3 Definitions. 

The definitions in ISO 13485 

(incorporated by reference, see § 820.7) 

apply to this part, except as specified in 

paragraph (b) of this section, and do not 

affect the meaning of similar terms 

defined in this title. 

(a) The following terms are necessary 

for the purposes of this part and do not 

appear in ISO 13485: 

Component means any raw material, 

substance, piece, part, software, 

firmware, labeling, or assembly that is 

intended to be included as part of the 

finished, packaged, and labeled device. 

Customer means persons or 

organizations, including users, that 

could or do receive a product or a 

service that is intended for or required 

by this person or organization. A 

customer can be internal or external to 

the organization. 

Design validation means establishing 

by objective evidence that device 

specifications conform with user needs 

and intended use(s). 

Federal Food, Drug, and Cosmetic Act 

means the Federal Food, Drug, and 

Cosmetic Act, 21 U.S.C. 321 et seq., as 

amended. 

Finished device means any device or 

accessory to any device that is suitable 

for use or capable of functioning, 

whether or not it is packaged, labeled, 

or sterilized. 

Human cell, tissue, or cellular or 

tissue-based product (HCT/P) regulated 

as a device means an HCT/P as defined 

in § 1271.3(d) of this chapter that does 

not meet the criteria in § 1271.10(a) of 

this chapter and that is also regulated as 

a device. 

Nonconformity means the 

nonfulfillment of a specified 

requirement. 

Process agent means any material or 

substance used in or used to facilitate 

the manufacturing process, a 

concomitant constituent, or a byproduct 

constituent produced during the 

manufacturing process, which is present 

in or on the finished device as a residue 

or impurity not by design or intent of 

the manufacturer. 

Process validation means establishing 

by objective evidence that a process 

consistently produces a result or 

product meeting its predetermined 

specifications. 

Remanufacturer means any person 

who processes, conditions, renovates, 

repackages, restores, or does any other 

act to a finished device that significantly 

changes the finished device’s 

performance or safety specifications, or 

intended use. 

Rework means action taken on a 

nonconforming product so that it will 

fulfill the specified requirements before 

it is released for distribution. 

Top management means those senior 

employees of a manufacturer who have 

the authority to establish or make 

changes to the manufacturer’s quality 

policy and quality management system. 

Verification means confirmation by 

examination and provision of objective 

evidence that specified requirements 

have been fulfilled. 

(b) All definitions in section 201 of 

the Federal Food, Drug, and Cosmetic 

Act shall apply to the regulation of 

quality management systems under this 

part and shall supersede the correlating 

terms and definitions in ISO 13485 (e.g., 

the definitions of device and labeling in 

sections 201(h) and (m) of the Federal 

Food, Drug, and Cosmetic Act apply to 

this part and supersede the definitions 

for the correlating terms in ISO 13485 

(labelling and medical device)). In 

addition, the following terms and 

definitions supersede the correlating 

term and definition in ISO 13485: 

Manufacturer means any person who 

designs, manufactures, fabricates, 

assembles, or processes a finished 

device. Manufacturer includes, but is 

not limited to, those who perform the 

functions of contract sterilization, 

installation, relabeling, 

remanufacturing, repacking, or 

specification development, and initial 

distributors of foreign entities 

performing these functions. 

Product means components, process 

agents, in-process devices, finished 

devices, and returned devices. 

§ 820.5 [Reserved] 

§ 820.7 Incorporation by reference. 

Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register under 5 U.S.C. 552(a) and 1 

CFR part 51. All approved material is 

available for inspection at the Food and 

Drug Administration, Dockets 

Management Staff, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 20852, 240– 

402–7500, and at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, email fr.inspection@nara.gov, or 

go to www.archives.gov/federal-register/ 

cfr/ibr-locations.html. It is available 

from the following source(s): 

(a) The International Organization for 

Standardization (ISO), BIBC II, Chemin 

de Blandonnet 8, CP 401, 1214 Vernier, 

Geneva, Switzerland; +41–22–749–01– 

11; customerservice@iso.org, https://

www.iso.org/store.html. 

(1) ISO 13485, ‘‘Medical devices— 

Quality management systems— 

Requirements for regulatory purposes,’’ 

third edition, dated March 2016; IBR 

approved for §§ 820.1; 820.3; 820.10; 

820.15; 820.35; 820.45. 

(2) [Reserved] 

(b) [Reserved] 

§ 820.10 Requirements for a quality 

management system. 

A manufacturer subject to this part as 

described by § 820.1(a) must: 

(a) Document. Document a quality 

management system that complies with 

the requirements of ISO 13485 

(incorporated by reference, see § 820.7) 

and this part; and 

(b) Applicable regulatory 

requirements. Comply, as appropriate, 

with the other applicable regulatory 

requirements in this title, including, but 

not limited to the following, to fully 

comply with the listed ISO 13485 

Clause: 

(1) For Clause 7.5.8 in ISO 13485, 

Identification, the manufacturer must 

document a system to assign unique 

device identification to the medical 

device in accordance with the 

requirements of part 830. 

(2) For Clause 7.5.9.1 in ISO 13485, 

Traceability—General, the manufacturer 

must document procedures for 

traceability in accordance with the 

requirements of part 821, if applicable. 

(3) For Clause 8.2.3 in ISO 13485, 

Reporting to regulatory authorities, the 

manufacturer must notify FDA of 

complaints that meet the reporting 

criteria of part 803 of this chapter. 

(4) For Clauses 7.2.3, 8.2.3, and 8.3.3, 

advisory notices shall be handled in 

accordance with the requirements of 

part 806. 

(c) Design and Development. 

Manufacturers of class II, class III, and 

those class I devices listed below must 

comply with the requirements in Design 

and Development, Clause 7.3 and its 

Subclauses in ISO 13485. The class I 

devices are as follows: 

(1) Devices automated with computer 

software; and 

(2) The devices listed in the following 

table: 

TABLE 1 TO PARAGRAPH (c)(2) 

Section Device 

868.6810 .. Catheter, Tracheobronchial Suction. 

878.4460 .. Glove, Non-powdered Surgeon’s. 

880.6760 .. Restraint, Protective. 

892.5650 .. System, Applicator, Radionuclide, 

Manual. 

892.5740 .. Source, Radionuclide Teletherapy. 

(d) Devices that support or sustain 

life. Manufacturers of devices that 

support or sustain life, the failure of 

which to perform when properly used 

in accordance with instructions for use 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10134 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

provided in the labeling can be 

reasonably expected to result in a 

significant injury, must comply with the 

requirements in Traceability for 

Implantable Devices, Clause 7.5.9.2 in 

ISO 13485, in addition to all other 

requirements in this part, as 

appropriate. 

(e) Enforcement. The failure to 

comply with any applicable 

requirement in this part renders a 

device adulterated under section 501(h) 

of the Federal Food, Drug, and Cosmetic 

Act. Such a device, as well as any 

person responsible for the failure to 

comply, is subject to regulatory action. 

§ 820.15 Clarification of concepts. 

Manufacturers subject to this part 

shall construe the following terms in 

ISO 13485 (incorporated by reference, 

see § 820.7) as follows: 

(a) Organization shall have the 

meaning of ‘‘manufacturers’’ as defined 

in this part. 

(b) Safety and performance shall have 

the meaning of ‘‘safety and 

effectiveness’’ for the purposes of this 

part. The phrase ‘‘safety and 

performance’’ does not relieve a 

manufacturer from any obligation to 

implement controls or other measures 

that provide reasonable assurance of 

safety and effectiveness. 

(c) Validation of processes shall have 

the meaning of ‘‘process validation’’ as 

defined in this part. 

Subpart B—Supplemental Provisions 

§ 820.20–§ 820.30 [Reserved] 

§ 820.35 Control of records. 

In addition to the requirements of 

Clause 4.2.5 in ISO 13485 (incorporated 

by reference, see § 820.7), Control of 

Records, the manufacturer must obtain 

the signature for each individual who 

approved or re-approved the record, and 

the date of such approval, on that record 

and include the below information in 

certain records as follows: 

(a) Records of complaints. In addition 

to Clause 8.2.2 in ISO 13485, Complaint 

Handling, the manufacturer must record 

the following information, at a 

minimum, for complaints that must be 

reported to FDA under part 803 of this 

chapter, complaints that a manufacturer 

determines must be investigated, and 

complaints that the manufacturer 

investigated regardless of those 

requirements: 

(1) The name of the device; 

(2) The date the complaint was 

received; 

(3) Any unique device identifier (UDI) 

or universal product code (UPC), and 

any other device identification(s); 

(4) The name, address, and phone 

number of the complainant; 

(5) The nature and details of the 

complaint; 

(6) Any corrective action taken; and 

(7) Any reply to the complainant. 

(b) Records of servicing activities. In 

adhering to Clause 7.5.4 in ISO 13485, 

Servicing Activities, the manufacturer 

must record the following information, 

at a minimum, for servicing activities: 

(1) The name of the device serviced; 

(2) Any unique device identifier (UDI) 

or universal product code (UPC), and 

any other device identification(s); 

(3) The date of service; 

(4) The individual(s) who serviced the 

device; 

(5) The service performed; and 

(6) Any test and inspection data. 

(c) Unique device identification. In 

addition to the requirements of Clauses 

7.5.1, 7.5.8, and 7.5.9 in ISO 13485, the 

UDI must be recorded for each medical 

device or batch of medical devices. 

(d) Confidentiality. Records deemed 

confidential by the manufacturer may be 

marked to aid FDA in determining 

whether information may be disclosed 

under the public information regulation 

in part 20 of this chapter. 

§ 820.40 [Reserved] 

§ 820.45 Device labeling and packaging 

controls. 

In addition to the requirements of 

Clause 7.5.1 of ISO 13485 (incorporated 

by reference, see § 820.7), Control of 

production and service provision, each 

manufacturer must establish and 

maintain procedures that provide a 

detailed description of the activities to 

ensure the integrity, inspection, storage, 

and operations for labeling and 

packaging, during the customary 

conditions of processing, storage, 

handling, distribution, and where 

appropriate, use of the device. 

(a) The manufacturer must ensure 

labeling and packaging has been 

examined for accuracy prior to release 

or storage, where applicable, to include 

the following: 

(1) The correct unique device 

identifier (UDI) or universal product 

code (UPC), or any other device 

identification(s); 

(2) Expiration date; 

(3) Storage instructions; 

(4) Handling instructions; and 

(5) Any additional processing 

instructions. 

(b) The release of the labeling for use 

must be documented in accordance with 

Clause 4.2.5 of ISO 13485. 

(c) The manufacturer must ensure 

labeling and packaging operations have 

been established and maintained to 

prevent errors, including, but not 

limited to, inspection of the labeling 

and packaging immediately before use 

to assure that all devices have correct 

labeling and packaging, as specified in 

the medical device file. Results of such 

labeling inspection must be documented 

in accordance with Clause 4.2.5 of ISO 

13485. 

Subparts C–O—[Reserved] 

Dated: February 8, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–03227 Filed 2–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 60 and 63 

[EPA–HQ–OAR–2021–0619; FRL–8602–01– 

OAR] 

RIN 2060–AV43 

Review of Standards of Performance 

for Lead Acid Battery Manufacturing 

Plants and National Emission 

Standards for Hazardous Air Pollutants 

for Lead Acid Battery Manufacturing 

Area Sources Technology Review 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: This proposal presents the 

results of the Environmental Protection 

Agency’s (EPA’s) review of the New 

Source Performance Standards (NSPS) 

for Lead Acid Battery Manufacturing 

Plants and the technology review (TR) 

for the National Emission Standards for 

Hazardous Air Pollutants (NESHAP) for 

Lead Acid Battery Manufacturing Area 

Sources as required under the Clean Air 

Act (CAA). The EPA is proposing 

revised lead (Pb) emission limits for grid 

casting, paste mixing, and lead 

reclamation operations for both the area 

source NESHAP (for new and existing 

sources) and under a new NSPS subpart 

(for lead acid battery facilities that begin 

construction, reconstruction, or 

modification after February 23, 2022). In 

addition, the EPA is proposing the 

following amendments for both the area 

source NESHAP (for new and existing 

sources) and under a new NSPS subpart 

(for lead acid battery facilities that begin 

construction, reconstruction or 

modification after February 23, 2022): 

Performance testing once every 5 years 

to demonstrate compliance; work 

practices to minimize emissions of 

fugitive lead dust; increased inspection 


khammond on DSKJM1Z7X2PROD with PROPOSALS