Medical Device Premarket Review - FDA Draft Guidance

For the first time, the U.S. FDA (Food and Drug Administration) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.

In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer’s ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.

Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.

Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.

The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.

Learn more:
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

FDA Medical Device Controversies - Approvals and Clearance

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I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows? It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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FDA Draft Guidance on Injectors

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To address the increasing popularity of drug-injector systems, the FDA (Food and Drug Administration) released a draft guidance, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. 

The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product. 

 The FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device intended for use with drugs and biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. 

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Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

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The FDA and medical device industry just got a wake-up call. Seems like this GAO report suggests greater rigor is needed in the premarket review process, MEDICAL DEVICES - FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. In any event, seems like this industry sector can expect potentially more rigorous regulation in the future . . . Bottomline, the reports states, "We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process." From your perspective, would more stringent regulation be a good thing? 

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Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

Updated November 5, 2024

The original link broke

You might also be interested in this article by the same author, Carl Anderson:

The FDA 483 - https://carl1anderson.wordpress.com/wp-content/uploads/2009/03/the-fda-483.pdf

---  the original post follows below  ---

The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

• About the Division of Bioresearch Monitoring Organization at CDRH
• Medical Device Sponsor Inspections
• Quality Systems in Clinical Trials
• Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

Related Posts:
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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New FDA Guidance - New Contrast Imaging Indication Considerations

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The FDA has just released this new guidance document, "Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (pdf)." 

To get quickly up to speed on the gist of the guidance, read this commentary posted on the FDA Law Blog, "FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling." 

In a nutshell, here's what the guidance covers . . . The guidance describes a process that allows either the imaging drug or imaging device developers to seek approval of medical imaging contrast indications using an already marketed imaging drug or biological product, including radiopharmaceuticals. 

 1. Device developers should generally submit a marketing application to add a new indication for using an already approved imaging drug under the circumstances described in this guidance. 1a. The data to establish these indications in a device application should include information developed in accordance with FDA existing guidance on Developing Medical Imaging Drug and Biological Products. 1b. For most types of indications as described in this guidance, when submitted to request marketing under a device application, the submission should be a Premarket Application (PMA). 

 2. Drug or biological product application holders of the already marketed imaging drug or biological product should generally submit an efficacy or labeling supplement, as appropriate, to add labeling for the new indication initially developed under a device application. 

 3. Device application holders may continue their current practice to request approval or clearance of labeling revisions for any new indications that may be initially approved in a supplement to the NDA for the imaging drug. 

 4. FDA expects to establish an internal intercenter imaging process to review and evaluate indications to ensure consistency in the development and review of clinical trials to establish the contrast indications that may be in either the drug or device labeling. 

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