Tag Archives: FDA

It’s Not About Faster Approvals, but About Better Availability, says FDA Commissioner Hamburg

By Sangita Viswanathan

Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.

Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.

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Reimbursement Report

PMA Approval and Third-Party Reimbursement

By Elizabeth Brown, MD

The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?

The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?

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What Changes Should Manufacturers Expect From FDA?

With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.

With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.

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Top 10 Reasons for FDA Warning Letters to Medical Device Firms

By Chris Celeste

The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.

The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.

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Reimbursement Report

Let’s Start at the Very Beginning

No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.

No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.

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Devine Guidance

So You Received a 483 from FDA, Deal with it!

By Dr. Christopher Joseph Devine

It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.

It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Article 16

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 16, of the Medical Device Directive delineates the requirements for “Notified Bodies.” The notified body is authorized to issue certification, and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or ineffective.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Article 15

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 15 provides guidelines for device manufacturers that have product or are planning to introduce product, into an EU Member State, for the purpose of conducting a clinical investigation. Failure to comply with this will result in device manufacturers failing to obtain approval to pursue clinical investigations within the EU, and in today’s increasingly complex medical device market, not performing a clinical investigation will result in device manufacturers being shut out of the European market.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Article 14b

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 14b, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Particular Health Monitoring Measures.” There are two takeaways from this edition of DG: One, a robust design and development process will lead to medical devices that are safe and effective; and two, devices that are safe and effective and meet their essential requirements seldom, if ever, will run afoul of Article 14b of the MDD.

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