Guidance and Reference Materials

Processes to accellerate FDA approvals, including of 510(k)s

Sept 2020. Lab and test standards and requirements.

"What factors should sponsors consider when deciding whether to change their clinical trial protocol during the COVID-19 public health emergency to include remote clinical outcome assessments?"

Oct 20. Devices made with certain GRAS fabrics, etc with direct or indirect contact with skin. {Includes useful info on 501(k) submissions in general.}

Non-binding recommendations

Find information about how to disinfect a public space like a store or school to combat the novel coronavirus (COVID-19).

"This recommendation is made as permitted under FIFRA section 2(ee) and has not been submitted to or approved by the EPA. All applicable directions, restrictions, precautions and Conditions of Sale and Warranty on the EPA registered label are to be followed."

Details for device labelers on complying with UDI requirements and submitting data to GUDID.

Are there any exceptions to the UDI requirements? Class I devices are entirely exempt from UDI requirements if FDA has exempted them from the good manufacturing requirements of 21 CFR 820. Class I devices that contain a Universal Product Code (UPC) on their labeling and packages are deemed to meet all UDI labeling requirements, but the labelers of such devices are still required to submit data to the GUDID. Other general exemptions include: Individual, single-use devices distributed in single packaging, Veterinary devices not intended for man distributed in single packaging

Overview and background of food facility registration and other submissions to CFSAN.

The U.S. Food and Drug Administration (FDA) announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, which was developed through a collaboration with the U.S. Environmental Protection Agency (EPA).

{Includes discussion of some age-dependent adjustment factors (ADAFs)}

{Info included on Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)}

July 2017. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.

"Historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies."

510(k) PREMARKET NOTIFICATION GUIDANCE for Contact Lens Care Products

The software-based tool “ToxRTool” (Toxicological data Reliability Assessment Tool) provides comprehensive criteria and guidance for evaluations of the inherent quality of toxicological data, thus making the decision process of assigning reliability categories more transparent and harmonised. ToxRTool consists of two parts, one to evaluate in vivo and one to evaluate in vitro data.The primary result of the tool is the assignment of Klimisch categories 1, 2 or 3 (Klimisch et al., 1997). Additionally, the tool offers the option to assign a Klimisch category according to personal judgement.

A Scientific Integrity Consortium developed a set of recommended principles and best practices that can be used broadly across scientific disciplines as a mechanism for consensus on scientific integrity standards and to better equip scientists to operate in a rapidly changing research environment. The two principles that represent the umbrella under which scientific processes should operate are as follows: (1) Foster a culture of integrity in the scientific process. (2) Evidence-based policy interests may have legitimate roles to play in influencing aspects of the research process, but thos...

The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of information to include in publications describing animal research.

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical ...

"Section 401 of FDAMA19 described certain conditions under which a drug or medical device manufacturer could choose to disseminate medical and scientific information that discusses unapproved uses of approved drugs and cleared or approved medical devices to “health care professionals and certain entities, including pharmacy benefits managers, health insurance issuers, group health plans, and Federal or State governmental agencies,” without such dissemination being considered as evidence of the manufacturer’s intent that the product be used 99 for an unapproved new use. Among those conditions was the expectation that the manufacturer of the product would seek FDA approval for the unapproved new use referenced in the disseminated literature." "FDA recommends that manufacturers employ the following practices if they choose to disseminate scientific and medical publications that include or may include information on unapproved new uses of approved, cleared, or 510(k) exempt products." “it is unlawful for a manufacturer to introduce a drug into interstate commerce with an intent that it be used for an off-label purpose”

"If a firm responds to... unsolicited requests for off-label information in the manner described above, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or uncleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising. "

"...if a firm communicates information that is not contained in its product’s FDA-required labeling but that is determined to be consistent... FDA does not intend to rely on that communication to establish a new intended use. " "Product communications that are consistent with a product’s FDA-required labeling but are false or misleading may subject a firm to enforcement action under the FD&C Act." "FDA views communications that do not trigger the need for a 510(k) to be consistent with the FDA-required labeling, and does not intend to rely on such communications to establish a new or significantly modified intended use, or one that is different from the use for which the product is legally marketed." "How does FDA determine whether a firm’s product communication is consistent with the FDA-required labeling?" ^Different indication; additional patients; conflict with limitations and directions for handling/use; conflict with dosing, use regimen, route administration, or strength^ ^not considered consistent: use of a product to treat different stage, severity, or manifestation of a disease than the product is approved to treat.^ "Therefore, FDA would not consider representations or suggestions in a CFL promotional communication to be false or misleading based only on the lack of evidence sufficient to satisfy the applicable approval/clearance standard." "...nformation should be presented in a way that does not overstate the conclusions that can be drawn from the supporting evidence."