Related Experiment Video
Updated: Mar 23, 2026
16:40
A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
27.0K
New technology in electrophysiology: FDA process and perspective
Kimberly A Selzman1, Mark Fellman2, Andrew Farb2
1Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Implantable Electrophysiological Devices Branch, WO66, Silver Spring, MD, 20993, USA. kimberly.selzman@fda.hhs.gov.
Summary
The Food and Drug Administration
Area of Science:
- Medical device regulation
- Public health
- Cardiac devices
Background:
- The Food and Drug Administration (FDA) regulates diverse products, including medical devices.
- The Center for Devices and Radiological Health (CDRH) within the FDA focuses on public health.
- Ensuring access to safe, effective, and high-quality medical devices is a key objective.
Purpose of the Study:
- To review the FDA's regulatory principles for cardiac devices.
- To highlight new FDA programs promoting medical device innovation and development.
- To discuss strategies for timely market approval of cardiac devices.
Main Methods:
- Review of FDA's overarching principles for cardiac device assessment.
- Analysis of newer FDA initiatives supporting device innovation.
- Examination of pathways for expedited market access.
Main Results:
- The FDA employs established principles for evaluating cardiac device safety and efficacy.
- New FDA programs aim to accelerate the development and review of innovative cardiac technologies.
- These initiatives seek to balance regulatory oversight with timely patient access.
Conclusions:
- The FDA's regulatory framework for cardiac devices prioritizes public health and safety.
- FDA programs are evolving to foster innovation and streamline market approval.
- These efforts are crucial for ensuring patients benefit from advanced cardiac technologies.
Related Concept Videos
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
63
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
63
01:11Clinical Trials: Overview
5.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.4K
01:26FDA Approved Drugs: Changes to Approved Drugs
320
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
320
01:28Preclinical Development: Overview
6.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.4K
01:25Drug Regulation
3.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.3K
01:26Drug Administration and Therapy Phases: Overview
1.6K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.6K