Medical Device Software PRD Template

The FDA defines SaMD as software intended to be used for medical purposes without being part of a hardware device. If your software diagnoses, treats, mitigates, or prevents disease, it is likely a medical device. Clinical decision support that merely presents information without providing a recommendation may be exempt under the Cures Act CDS exemption (21st Century Cures Act, Section 3060). Consult an FDA regulatory specialist if you are uncertain.

A 510(k) requires you to demonstrate that your device is "substantially equivalent" to a legally marketed predicate device. It is faster (3-6 months) but requires a valid predicate. De Novo is for novel devices that have no predicate but are low-to-moderate risk. It takes longer (6-12 months) but establishes your device as the predicate for future entrants. Choose 510(k) if a predicate exists; choose De Novo if your device is genuinely new.

For a well-prepared 510(k) submission: 3-6 months from submission to clearance. For De Novo: 6-12 months. These timelines assume no major deficiencies in the submission. FDA review cycles include a substantive review period, potential additional information requests (AI letters), and final decision. Budget 12-18 months total from starting submission preparation to clearance.

ISO 13485 (Quality Management Systems for Medical Devices) is not legally required by the FDA, but it is required for CE marking in the EU and is considered best practice. Many health system procurement teams require ISO 13485 as a vendor qualification criterion. If you plan to sell internationally or to large US health systems, pursue certification. It takes 6-12 months to implement and certify.

FDA distinguishes between changes that require a new 510(k) submission and those that do not. Changes that affect the intended use, alter the risk profile, or modify the clinical algorithm typically require a new submission. Bug fixes, UI improvements, and performance optimizations typically do not. Document your change assessment using FDA's guidance on deciding when to submit a 510(k) for a change to an existing device. Maintain a change log and risk assessment for every release. ---