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Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products.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

FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017

The Food and Drug Administration (FDA) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.

Read the final ruling here.

Pharmaceutical and Medical Device Recalls – Statistics and Facts (Statista.Com)

A product recall occurs when safety issues or defects in a product are found that might endanger consumers, or put the producer or seller at risk of legal action. When this happens, the product is taken off the market resulting in financial loss for the producing company and potential damage to the company’s reputation.

Product recalls in the pharmaceutical industry are not rare. For example, in the first quarter of 2018, 84 companies in the U.S. reported at least one recall. For pharmaceutical companies, the cost of the actual recall is not the most costly aspect of recalls. Around half of pharmaceutical product recall costs result from the subsequent interruption to business that the recall causes. 

Similarly, medical devices are also regularly recalled, with the main cause of recalls involving software and quality issues. In FY 2017 alone, the FDA inspected 2,652 establishments where medical devices were manufactured, processed, packed, installed, used, implanted or where records of results from use of such devices were kept. Furthermore, the FDA issues Warning Letters to companies concerning medical devices and potential problems associated with them. 

Read more about this topic on Statista.Com.

FDA’s New Data Integrity Guidance — Highlights & Observations

The scope of the FDA document includes drugs, biologics, and positron emission tomography drugs. The agency also states the requirements are consistent with the requirements in ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, thus expanding the scope of the document to APIs and drug substances. The FDA states it is the “role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value. …”

Read more here.

FDA Clarifies Human Subjects Protection Expectations

A new guidance from the U.S. Food and Drug Administration (FDA) provides welcome direction to sponsors, investigators, and institutional review boards (IRBs) on human subjects protection.

The guidance is one of the agency’s follow-ups to its revisions of the “Common Rule” (Federal Policy for the Protection of Human Research Subjects), which became effective in July 2018. General compliance for the revised Common Rule is mandated to begin in January 2019. The purposes of the Common Rule are to promote “uniformity, understanding, and compliance with human subject protections and to create a uniform body of regulations across federal departments and agencies,” FDA explains in the new guidance.

The requirements contain several new areas of informed consent, including changes relating to the content, organization, and presentation included in the consent form. It also clarifies the process to facilitate a prospective subject’s decision about whether to participate in research. FDA is clarifying the provisions to help sponsors and investigators develop, and IRBs implement, two separate informed consent forms.

The guidance also follows up on earlier FDA rules which allowed IRBs to use expedited review procedures for certain kinds of research involving “no more than minimal risk.” The new guidance includes a list of categories that may qualify for the fast track, while it also makes clear that, as appropriate, IRB reviewers must find that the research on the list involved no more than minimal risk.