New Guidance from FDA to Accelerate COVID-19 Treatments

(RAPS, 5/12/20) The US Food and Drug Administration (FDA) on Monday evening issued two guidances intended to accelerate the development of products to treat or prevent coronavirus disease (COVID-19), laying out recommendations to help companies get to the investigational new drug application (IND) stage and clinical trial design considerations for later-stage studies.

Read more here.

Remote Release and Remote Audits: New Answers from the EU

From ECA Academy

The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. 

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Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

FDA has temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.

Read more here.

FDA Emergency Use Authorization for in vitro diagnostics (COVID-19)

On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of this determination, the Secretary then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. 

Read more here.

Newly Revised ISO Standard Will Help Device Manufacturers Address Risk Management

(from RAPS, December 2019)

The International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and additions from the previous version.

The revised standard, known as ISO 14971:2019, replaces the second edition from 2007 and introduces several new definitions on the terms “benefit,” “reasonably foreseeable misuse” and “state of the art.”

Read more here.

Premarket Submissions for Non-Clinical Bench Performance Testing

Do you know the content and format requirements for submitting Premarket Submissions for Non-Clinical Bench Performance Testing?

Recent FDA guidance describes the relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission. These submissions include: premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests.
This guidance will ensure you provide the correct information to avoid delays in your submission review process.

Download the guidance here.

Quality Requirements for Drug-Device Combinations

(from European Medicines Agency): Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately.

Download the guidance here.

FDA: Initiation of Voluntary Recalls

From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products.

Download the proposed rules here.