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Europe 93/42/EC and 98/79/EC directives Medical devices EC mark Diagnostic in vitro devices EC mark	USA FDA - CDRH 21 CFR Quality system requirements Medical devices registration 510(k) Pre market approval FDA inspection
FRANCE Adverse side effects notification Device registration Special authorization prior marketing Clinical investigations	CANADA Medical devices registration

FDA - CDRH

CDRH DATA BASE

http://www.fda.gov/cdrh/databases.html

Current comprehensive list of all CDRH guidance documents, most recent revision of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs, listing of medical devices in commercial distribution by both domestic and foreign manufacturers, adverse events, releasable 510(k)s and PMA, classification database, FDA recognized consensus standards

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21 Code of Federal Rules

Chapter	European Equivalence
PART 801 LABELING	93/42/EC Directive Annex I Point 13
PART 803 MEDICAL DEVICE REPORTING	Code of the public Health (France) AFSSAPS
PART 806 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS	Code of the public Health (France) AFSSAPS
PART 807 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES	93/42/EC Directive Article 14 - EUDAMED Registration (France)
	Evaluation of conformity (Dir 93/42/CE Annexes II to VII)
PART 810 MEDICAL DEVICE RECALL AUTHORITY	93/42/EC Directive Article 10 - AFSSAPS (France)
PART 812 INVESTIGATIONAL DEVICE EXEMPTIONS	Huriet’Law (France) – ISO 14125
PART 814 PREMARKET APPROVAL OF MEDICAL DEVICES	Evaluation of the conformity (Dir 93/42/EC Annexes II to VII)
PART 820 QUALITY SYSTEM REGULATION	ISO 9001 / 13485 and 93/42/CE Directive Annex I
PART 821 MEDICAL DEVICE TRACKING REQUIREMENTS	ISO 9001 / ISO 13485

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Quality System Requirements

21 CFR Part 820	ISO 13485 (2003)
820.20 Management responsibility
a) Quality policy	5.3 Quality policy + 5.4.1 Quality objectives
b) Organization	5.5.1. Responsibility and authority 5.1 Management commitment point e + 6.2 Human resources
3/. Management representative	5.5.2 Management representative
c) Management review	5.6 Management review
d) Quality planning	5.4.2 Quality management system planning
e) Quality system procedures	4.2 Documentation requirements
820.22 Quality audit	8.2.2 Internal audit
820.25 Personnel
a) General	5.1 Management commitment + 6.2. Human resources
b) Training	6.2.2 Competence, awareness and training
820.30.Design controls	7.3. Design and Development
820.40. Document controls	4.2.3 Control of documents
820.50.Purchasing controls	7.4. Purchasing
820.60.Identification	7.5.3 Identification and traceability
820.65.Traceability	7.5.3 Identification and traceability
820.70.Production & process controls
a) General	7.1 Planning of product realization
b) Production and process changes
c) Environmental control	6.4 Work environment
d) Personnel	6.4 Work environment
e) Contamination control	7.5.1. Control of production and service provision
f) Buildings	6.3 Infrastructure
g) Equipment	7.6 Control of monitoring and measuring devices
h) Manufacturing material	6.3 Infrastructure
i) Automated processes	7.5.2. Validation of processes for production
820.72.Inspection, measuring, and test equipment	7.6 Control of monitoring and measuring devices
820.75.Process validation	7.5.2. Validation of processes for production
820.80. Receiving, in-process, & finished device acceptance.
b) Receiving acceptance	7.4.3 Verification of purchased product
c) In process acceptance	8.2.4 Monitoring and measurement of product
d) Final acceptance	8.2.4 Monitoring and measurement of product
e) Acceptance records	4.2.4 Control of records
820.86. Acceptance status	8.2.4 Monitoring and measurement of product + 8.3 Control of non conforming product
820.90.Non conforming product	8.3 Control of non conforming product
820.100.Corrective & preventive action	8.5.2 Corrective action 8.5.3 Preventive action
820.120.Device labeling	EC 93/42/Dir + 7.5.1. Control of production and service provision + 7.5.1.1 point g + 7.5.3.2 Traceability
820.130. Device packaging.	7.5.2. Validation of processes for production + 7.5.1.1 g
820.140.Handling	7.5.5 Preservation of product
820.150.Storage	7.5.5 Preservation of product
820.160.Distribution	7.5.3.2 Traceability
820.170 Installation	7.5.1.2.2. Installation
820.180.Record - general requirements	4.2.4. Control of records
820.181. Device master record	EC / Technical File
820.184. Device history record	Batch / lot file
820.186. Quality system record	4.2 Documentation requirements
820.198 Complaint files	8.2.1 Feedback 7.2.3. Customer communication
820.200. Servicing	7.5.1.Control of production and service provision
820.250. Statistical techniques	8.2.3 Monitoring and measurement of processes 8.2.3 Monitoring and measurement of processes 8.4. Analysis of data

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Medical Devices Registration

Classification :

• by FDA
• based on the criticity of the product
• specified intended use
• modalities described in 21CFR 862 to 892

3 Classes of device :CLASSES I, II et III : from less critical to most critical

3 Levels of registration

GENERAL CONTROL Administrative registration cGMP conformity (21CFR820) Labeling conformity (21CFR 801)

SPECIAL CONTROL « General control » Pre market notification (510k) +/- Traceability, post market surveillance, conformity to standards …

PRE MARKET APPROVAL « General control » PMA (PDP, IDE) Traceability, Post market surveillance Conformity to standards

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510(k)

Procedure	« Special » 510(k)	« Abbreviated » 510(k)	« Traditional » 510(k)
Applicable when	Modification to a previously registered medical device 510(k)	Existing FDA Guidance	Other cases
Predicate device	Initially registered medical device	Predicate device	Predicate device
Description	YES	YES	YES
Labeling	YES	YES	YES
Table of Equivalence	YES	YES	YES
Performance data	Testing reports	Conformity to Guidance Conformity to standards	Testing reports

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PRE MARKET APPROVAL

Procedure	PMA	IDE	PDP
	Pre Market Approval	Investigation Device Exemption	Product Development Protocol Alternative au PMA
Applicable when :	Some Class III medical devices	Medical devices to be used for clinical trial	Alternative to PMA
Regulation :	21CFR PArt 814	21 CFR Part 812	21CFR PArt 814
File content :	Description of the medical device Scientific Validation Biological Evaluation Pre clinical Assays Clinical Investigations Manufacturing process Labeling	Clinical Investigation Plan State of the Art Patient consent Qualified Investigators Specific labeling	Transmission of the documents to the FDA according to a specified planning

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FDA INSPECTION

• Management controls
• Corrective and preventive actions (CAPA)
• Design controls
• Production and process controls
• Medical device reporting - medical device tracking- reports of corrections and removals

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