Medical Device Regulatory Path

Step 3: Pathway to Approval | FDA

https://www.fda.gov/patients/device-development-process/step-3-pathway-approval

Premarket Approval (PMA) PMA refers to the scientific and regulatory review necessary to evaluate: devices that were found not substantially equivalent to a Class I or II predicate through the 510 ...

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Regulatory Controls | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

MEDICAL DEVICES: FDA regulatory pathways for …

https://www.topra.org/topra/topra_member/pdfs/CPD-May-2019-Medical-Devices-and-FDA.pdf

the device. Because medical devices vary widely in their complexity and benefits or risks, they do not require the same degree of regulation. Thus, the FD&C Act established the …

De Novo Classification Request | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

The FDA issued a final rule to establish new regulations implementing the medical device De Novo classification process under the FD&C Act (section 513(f)(2) …

7 FDA Pathways to Bring Your Medical …

https://www.greenlight.guru/blog/fda-pathways-medical-device-to-market

CDE devices are exempt from PMA or 510(k) submission process but the company still needs to comply with the following regulations: Design Controls (21 CFR Part 820) Medical …

Premarket Approval (PMA) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval of Medical Devices. A Class …

6 Regulatory Pathways to Bring Your Medical …

https://blog.sierralabs.com/6-regulatory-pathways-to-bring-your-medical-device-to-market

Here are the 6 Regulatory Pathways for Medical Devices: Pre-Market Notification 510 (K) Pre-Market Approval (PMA) Product Development Protocol (PDP) De Novo. Humanitarian Device Exception (HDE) …

Which Regulatory Pathway Is Right For Your Medical …

https://www.meddeviceonline.com/doc/are-you-sure-you-know-the-best-regulatory-pathway-for-your-new-medical-device-0001

Only about 5 percent of devices brought to market are PMAs. For reference, it costs about $31 million to bring a medical device onto the market under the 510 (k) …

Career Pathways in Regulatory Affairs

https://www.raps.org/news-and-articles/news-articles/2020/3/career-pathways-in-regulatory-affairs

This “how-to” article discusses career pathways in regulatory affairs. The author traces her career path as she grew from an administrative assistant to regulatory generalist to vice …