40 CFR Part

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

Table 6.2 Correlation between the requirements of 21 CFR Part 314,50 and the CTD format.

Good manulacluring practice regulations In 21 CFR Parts 210.211 or applicable regutalions. Parts 696, arnlfor 620-... 

U S Code of Federal Regulations 21 CFR Part 314 21 CFR Part 514 21 CFR Part 601 U S Food, Drug Cosmetic Act Chapter 5, Sub chapter B, F... 

The regulation of medical devices in the U S was introduced with the Medical Device Amendments to FDC Act in 1976. These are supported by regulations published in 21 CFR parts 800-899. The Center for Devices and Radiological Health (CDRH) is the responsible section within the FDA for regulation of devices. 

The conduct of studies of medical devices in the US that have not been cleared/ approved by the FDA is regulated via Investigational Device Exemption (IDE) regulations set out in 21 CFR Part 812. Considering the type of device and the level of associated risk involved, investigations maybe conducted as IDE-exempted studies. Abbreviated requirement studies, or studies subject to full IDE requirements. 

Investigational Device Exemptions - 21 CER Part 812 Pre market approval - 21 CFR Part 814... 

Part 108 Part 109 Part 113 Part 114 21 CFR Part 225 Part 226 Part 600 Part 606 Part 610 Part 630 Part 640 Part 660 Part 680... 

Sec. 820.130 Device packaging - Packaging must provide adequate protection of the device Figure 11.15 Headings of the Quality System Regulations (QSR) from 21 CFR Part 820. 

Computer System Validation US Code of Federal Regulations 21 CFR Part 11. 

FDC Act Section 510, Registration of producers of drugs and devices Establishment Registration 21 CFR Parts 207 (drugs), 607 (blood/blood products) and 807 (devices)... 

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

CFR Part 11 Software Evaluation Checklist for Closed Systems That Do... 

Yet under the original requirements of 21 CFR Part 11 both companies would have had to conduct extensive test on the software to write and implement eight to ten standard operating procedures to document the requirements, development, and change history of the code and to record and archive all records. In this case, as in so many, such an investment in time and dollars would have been justihed for the pacemakers but wasted in the case of the tongue depressors. 

When his analysis uncovered this and other similar situations, McClellan took two unusual steps. First, he suspended Part 11, calling for reconsideration. And second, four months later, he re-released 21 CFR Part 11 with some major changes in interpretation. 

The checklist also serves as a summary of and operationalization of the complex Part 11 requirement. When an auditor—either an independent expert or an FDA investigator—can check as compliant all identified issues, the system is de facto operating under the letter and spirit of 21 CFR Part 11. Any issue that emerges as questionable, unclear, noncompliant, or absent requires investigation, explanation, and remediation. 

Presented is a model checklist divided into two parts a general checklist of 21 CFR Part 11 requirements and a 21 CFR Part 11 software evaluation checklist for closed systems that do not use biometrics. 

CFR PART 11 SOFTWARE EVALUATION CHECKLIST FOR CLOSED SYSTEMS THAT DO NOT USE BIOMETRICS... 

Only those sections of 21 CFR Part 11 that describe technical controls required for 21 CFR Part 11 compliance of closed systems are included in this checklist (Table 26.1). Sections that describe only procedural controls [11.10(i), (j), (k) 11.100(b), (c) 11.300(c)] that cannot be implemented by a software product or additional controls for open system (11.30) are not included. Procedural controls can only be exercised during the implementation of a 21 CFR Part 11-compliant system of which the software is a component. 

Colorants exempt from certification are derived from animal, vegetable, or mineral origin or are synthetic duplicates of naturally existing colors. They contain complex mixtures of numerous components and are listed in 21 CFR, part 73. 

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