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1. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101713256-pdf

2. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719884-pdf

3. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719885-pdf