Whether you are sure the product you plan to launch without FDA clearance is an exempt device or not, call PDG®. Our consultants will assist you in the compilation of a regulatory dossier to support marketing of the product to be retained with your records in case of an FDA audit. The Benefits of the…
There are a number of pre-submission meetings and review procedures available to the device industry seeking advice from FDA during the developmental stages of IDEs, 510(k)s and PMAs. PDG can help maximize the value of your interactions with CDRH through the 510(k) Pre-Submission Program, pre-IDE Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, Submission…
To help prepare for FDA facility inspections, PDG device consultants are available to review, improve and implement quality control, quality assurance, document control, and complaint handling procedures. Improve FDA Facility Inspection Readiness with Mock FDA Audits We also prepare our clients for FDA inspections by conducting mock audits to include third party facilities such as,…
Generally speaking, a combination product is composed of any combination of a device/drug, device/biologic, drug/biologic or combination of all three, including co-packaged products. Combination products are often confused with fixed combination dose (FCD) drug products, which are comprised of drug/drug combinations. Because PDG’s team of device consultants and pharmaceutical consultants possess industry expertise in the…
PDG’s 510(k) compilation consists of a series of steps designed to ensure that CDRH accepts the filing. The first step is to determine (to the extent possible) that the 510(k) is the most appropriate regulatory pathway including whether traditional, special or abbreviated 510(k). This is followed by a data review of the device records, comparing…
FDA requires PMAs for high-risk Class III medical devices and in certain cases, innovative technology where no predicate may be identified. The PMA submission and review process is more complex and takes much longer than a 510(k) submission. As one might imagine, the PMA submission requires considerable preparation and resources, due largely to the requirement…